The returned device was assembled with the mating device helical blade/screw coupling screw, it was noticed the it was not tightening properly due to some resistance.Hence, the complaint is confirmed.It is possibly due to the stripped condition of internal thread of the device.The exact cause of the reported condition is unknown, but, it is likely that the device was subjected to excessive forces during the 4+ year life of the device.After a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities device history lot: part number: 03.037.024, lot number: t118565, manufacturing site: (b)(4), release to warehouse date: 14-apr-2015.A review of the device history records was performed for the finished device lot number, and no non-conformance's 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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It was reported that on (b)(6) 2019, during equipment check, one (1) flexible hexagonal screwdriver snapped in half due to improper handling, two (2) flexible shaft bent and un-usable, one (1) helical blade inserter, is caught in with the coupling screw and the inserter handle and won¿t advance, one (1) helical blade/screw coupling screw will not advance and therefore cannot engage the blade, they were discovered damaged in the sterile processing department.There was no patient involvement.This is 5 of 5 for report (b)(4).
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