Catalog Number 5530-T-616B |
Device Problems
Crack (1135); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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The 6x16mm tibial insert trial cracked down the middle upon impaction during trial reduction.The #6 tibial baseplate trial was being held in place with two pins in the posterior fixation holes.The #6 cr femoral trial was in place on the femur.The insert impaction tool from the miscellaneous instrument tray was used to strike the insert into place in a flexed position.An alternative trial already available in the sterile field was used to continue the case.
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Manufacturer Narrative
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An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis has been performed.The report concluded: ¿the fracture occurred in fast fracture through the center of the device.The origin was found to be inside the material at the interface between the first and second injection molding shots.¿ -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed.The parts are injection molded by mack medical.Due to reports of cracks, sample parts were pulled from fg for evaluation.Lack of fusion areas were observed between the first and second shots of the two-shot trials.The reported device has been identified to be in the scope of an internal non conformance for the reported failure mode.
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Event Description
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The 6 x 16 mm tibial insert trial cracked down the middle upon impaction during trial reduction.The #6 tibial baseplate trial was being held in place with two pins in the posterior fixation holes.The #6 cr femoral trial was in place on the femur.The insert impaction tool from the miscellaneous instrument tray was used to strike the insert into place in a flexed position.An alternative trial already available in the sterile field was used to continue the case.
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Search Alerts/Recalls
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