Product complaint #: (b)(4).Reporter is a synthes rep.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, that the symphony screwdriver retainer sleeve is defective.The inner shaft will not slide down the retainer sleeve, therefore, it has been confirmed that the retainer sleeve as the inner shaft would slide down another retainer sleeve.Set has only been used 5 or 6 times.No apparent defect is visible, but something is damaged.This did not impact the case as another set was used.It was caught when scrub tech was setting up instruments before surgery.Two sets and one other bad retainer sleeve were checked.There is no patient involvement.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the poly screw driver reten sleeve (p/n: 202000401, lot number: pc4992896) was received at us cq.Upon visual inspection, the most proximal thread on the device was stripped.No other issues were identified with the returned device.Functional test: a functional assessment could not be performed on the complaint device since a mating device was not returned.Dimensional inspection: shaft inner diameter was measured and found to be conforming as per relevant drawing.Document/specification review: relevant drawings were reviewed and no design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as a functional test cannot be performed on the device to confirm the unable to assemble allegation.However, the most proximal external thread is stripped.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number (b)(4) was released in a single batch.Batch1: lot qty of (b)(4) units were released on 06mar2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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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