Additional device product code: hxq.A product investigation was conducted.Visual inspection: the applic-forceps f/rapidsorb cranial clamp (p/n: 329.317, lot #: a7pa46) was returned and received at us cq.Upon visual inspection, the distal portion of the push arm component was observed to be slightly broken and rust was observed on the upper jaw component.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.The overall functional test was not performed as the device was returned by itself.However, the push arm was observed to be broken which could have caused the complaint condition.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed for the (b)(6) (p/n: 02.118.401, lot # h771082).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.A device history record (dhr) review was conducted: part: 329.317.Lot: a7pa46.Manufacturing site: (b)(4).Supplier: chr.Diener gmbh & co.Kg.Release to warehouse date: 23.Nov.2006.A manufacturing record evaluation was performed for the finished device lot number, 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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