quality
Orthopaedic implant and instrument marking meets
legislative and consumer traceability requirements for Comis Orthopaedics
Identity security
Pryor’s HP20 Nd:Yag
laser marker with a V2
enclosure. This floorstanding
machine has
4-axis control, 160mm
focal length lens and
includes an electrical
Z axis.
COMIS Orthopaedics is a privately owned business
set up in December 2005 to design, develop, manufacture
and market implants and instrumentation for Minimally
Invasive Surgery (MIS). Its innovative product range
includes the patented Minimally Invasive Hip Resurfacing
or Comis MIHR, that is deliverable as an open surgery
implant; the Comis Leg Length System which provides an
initial datum measurement of the joint position prior to
dislocating a hip joint; and the MIS Retractor System,
designed for near assistant-free use in hip resurfacing and
total hip arthroplasty. The company makes a range of
other devices and surgical instrumentation, manufactured
on site at its factory in Rotherham, with implant
production sub-contracted to specialists LPE Medical. UK
market distribution is handled by JRI.
From the start, Managing Director Shaun Palmer and
his colleague Ryan Taylor, General Manager, knew that
they would need to ensure full traceability on every part
they made, to meet the strict legislative requirements and
customer demands in the orthopaedic market. They
decided to implement high-tech laser marking as the
industry standard, state-of-the art marking method. A
laser marks directly into the product’s surface, a process
that ensures long-term traceability throughout the
product life cycle that includes frequent handling,
cleaning and storage.
Every product can be made from different materials
and will undergo several processes before it reaches final
product stage. For example, a batch of 17 parts could be
manufactured from a number of materials. Each batch
will be given a lot number. If a recall was required based
on the return of one product, the other 16 customers could
be contacted through the use of the traceable identifier
and the whole process monitored. As Ryan Taylor says:
‘You have to be aware of where the products are for recall -
you need to know who can be at risk.’
Comis Orthopaedics approached Pryor Marking
96 MWP march 2008
Technology, a leading provider of marking and
traceability solutions based in Sheffield. The chosen
system was Pryor’s HP20 Nd:Yag laser marker with a V2
enclosure, which was installed in September 2006 when
the manufacturing site opened. This floor-standing
machine has 4-axis control, 160mm focal length lens and
includes an electrical Z axis. It also has a useful
circumferential fixture, an adjustable marking platform
of 200 by 200mm and fume control for use on polymer
marked plastics.The system is controlled using the
PryorLaser professional marking software on a PC
connected directly to the laser system.
A particular feature of the Pryor equipment is its
functionality as a diode marker - it maintains the integrity
of the mark, even after acid passivation. Some other kinds
of mark would disappear or show signs of corrosion
during this process but the capability to program the
marker’s Q-switch to an unusually high frequency enables
marks to be achieved which survive the passivation process
and also overcome the problems of mark corrosion.
Taylor explains the rationale for investing in the Pryor
system: ‘We know from previous experience that we used
to use a sub-contracted marking firm which would charge
for each different part. There was a £25 set-up charge and
then £1.50 charge per mark. We can now do the same
marking in-house (and more) for about 50p per mark.
There is a definite cost saving to Comis Orthopaedics, but
there is also the convenience that we can mark everything
on site that we need to. As well as marking the parts for
traceability purposes during the manufacturing process,
before they are sold, we have taken the step of marking all
of our jigs and fixtures. We mark it all. If parts are hard to
handle during manufacturing, we would make a special
jig to hold it and we mark those too so that they are easily
identifiable and not accidentally discarded.’
www.pryormarking.com
www.comisorthopaedics.com
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