Device evaluated by mfr: part: 391.900, lot: t199243.Manufacturing site: (b)(4).Release to warehouse date: september 15, 2020 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the small wire cutter 160mm was returned and received at us customer quality (cq).Upon visual inspection, that there is a slight gap between the cutters jaws and therefore are not closing properly and the jaws are slightly deformed.No other issues were identified with the returned components of the device.Functional test was not performed but the alleged dull/will not cut can be confirmed since there is gap between jaws and they are deformed.Dimensional inspection: 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.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed: cable cutter pinch-large orthopaedic cable system.Investigation conclusion: the complaint condition is confirmed for the small wire cutter 160mm.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.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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