Part # 319.007, synthes lot number: 4963260, manufacturing site: (b)(4), release to warehouse date: 18-mar-2005, no ncr¿s were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws, long (p/n 319.007 s/n (b)(4)) was received at customer quality, and upon visual inspection, a vertical crack was observed in orange colored section of body part.The needle, nose piece, and slider were found intact.The complaint is of broken is confirmed.Device failure/ defect identified? yes.Dimensional inspection: the design, materials and finishing processes were found to be appropriate for the intended use of this device.A dimensional inspection was not necessary given the nature of the complaint and product type.Document/ specification review: respective drawings were reviewed.No product design issues or discrepancies were observed during this investigation.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformance's were identified.Complaint confirmed? yes.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 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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It was reported that, on (b)(6) 2019 a titanium (ti) mini locking plate and a depth gauge were found broken during the audit of returned devices at millstone facility.There was no patient involvement.This complaint involves two (2) devices.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws, long.This is report is 2 of 2 for (b)(4).
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