Additional narrative: date of event: unknown.Initial reporter is j&j company representative.Investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that bend-templ f/matrixmand-pref-reco-pl med was observed with signs of usage, the body section bent and the ramus broken.The broken ramus part was received in the evidence provided.A dimensional inspection for the bend-templ f/matrixmand-pref-reco-pl was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the bend-templ f/matrixmand-pref-reco-pl med would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: no issues dimensional inspection: n/a.Device history: part # 03.503.911, lot # 8145510, manufacturing site: (b)(4), release to warehouse date: 18 feb2015, supplier: diener ag precision machining.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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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