Part 391.962, lot t156261: manufacturing site: (b)(4).Release to warehouse date: january 18, 2018.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.A product investigation was completed: upon visual inspection, the carbide insert broken off at the cutting slot of the device and a resistance was observed in opening /closing due to friction.No other issues were observed with the returned components of the device.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Based on the date of manufacture the drawings, reflecting the current and manufactured revision were reviewed.The complaint condition is confirmed as broken carbide insert can cause the reported condition.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.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 on (b)(6) 2020, during an inspection, it was found that the bending/cutting pliers failed to cut the maxframe wire.There was no patient involvement.During investigation of the returned device by the manufacturer, it was noted the carbide insert broken off at the cutting slot of the device and a resistance was observed in opening /closing due to friction.Concomitant device reported: maxframe wire (part unknown, lot unknown, quantity 1).This report is for a bending/cutting pliers.This is report 1 of 1 for (b)(4).
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