STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON GAP BALANCER-SIZER; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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Catalog Number I-K2710KB00 |
Device Problems
Device Damaged Prior to Use (2284); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that during a tka procedure on patient's left knee, the surgeon realized the balancer instrument was damaged (nature unknown).The instrument did not register the proper femoral size.Company rep reported that this instrument was used in a case the previous day and had malfunctioned and "we thought we had fixed it".An old style a.P.Sizer which was immediately available was used instead.There was no surgical delay, no adverse affects to the patient, and that the procedure was completed successfully.
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Manufacturer Narrative
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An event regarding non-function involving a specialty guide was reported.The event was confirmed.Device evaluation and results: visual inspection of the returned device revealed that the two locking screws near the lock handle were missing.Tool marks were observed on the screw head on the back face of the device.The missing locking screws and tool marks suggest that the balancer had been disassembled.Discussion with specialty confirmed that the device was disassembled and assembled incorrectly.The specialty team was able to proper reassemble the instrument but indicated it still wouldn't function without the locking screws around the handle.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the instrument is non-functional as the locking screws near the lock handle were missing.Tool marks observed on the screw head on the back face of the device indicate the instrument was disassembled and then re-assembled incorrectly.Review of appendix 1 for instruments requiring disassembly for cleaning for total knee arthroplasty instruments did not include the device reported in this investigation.Therefore, there is no just cause for the triathlon gap balancer to be disassembled during use or preparation.
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Event Description
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It was reported that during a tka procedure on patient's left knee, the surgeon realized the balancer instrument was damaged (nature unknown).The instrument did not register the proper femoral size.Company rep reported that this instrument was used in a case the previous day and had malfunctioned and "we thought we had fixed it".An old style a.P.Sizer which was immediately available was used instead.There was no surgical delay, no adverse affects to the patient, and that the procedure was completed successfully.
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Search Alerts/Recalls
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