Part #: 280.29 lot #: 6533836 manufacturing site: (b)(4), supplier: synthes usa hq, inc, release to warehouse date: 29 nov 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the dhs/dcs-scr ø12.5 l90 octagonal-coupl ss (part #: 280.29, lot #: 6533836) was received at us customer quality (cq).Visual inspection showed that the device was severely scratched and nicked.It was also observed to be slightly deformed at the proximal end around the hole.Functional test: during functional assessment, the device was assembled with its mating device (the second returned device).Both devices stuck together but after wiggling and pulling in opposite directions both devices; they came apart; hence this complaint is confirmed.Can the complaint be replicated with the returned device? yes.Dimensional inspection: measured dimensions, flat diameter: conform, round diameter: conform.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device was severely scratched and nicked.It was also observed to be slightly deformed at the proximal end around the hole.This condition of the device contributed to the reported condition of jammed/seized.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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