Investigation summary: visual inspection: the tap for 2.0mm cortex screws 54mm was received at customer quality, and it was observed that the device was broken into two pieces along the threaded shaft.The threaded portion was the device was not returned to us cq.The complaint is confirmed.The device was broken into two pieces along the threaded shaft.Conclusion: the measuring result does show conformity.The diameter ø2.35 +0/- 0.016mm of the shaft got measured.Drawing: 2.0mm tap, 311_19 revision c, shaft diameter: ø2.35 +0/- 0.016mm, caliper: ca 215p, measured diameter = ø 2.34 mm.Conclusion: the measuring result does show conformity.The manufacturing record evaluation was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 311.190, lot: 2726007, manufacturing site: (b)(4), release to warehouse date: jul 07, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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