Reporter is a synthes employee.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 during sterile processing on (b)(6) 2020, the paint or white calibrated etching of four (4) depth gauge for locking screws were noticed to had faded away after decontamination and four (4) depth gauge for locking screws had missing ball bearings that help provide stability to the depth gauge.Without the bearing, the two pieces fall apart easily.There was no patient involvement.This complaint involves eight (8) devices.This is 2 of 4 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary.Visual inspection: the depth gauge for locking screws to 100mm for im nails (p/n: 03.010.072, lot number: 8364730) was received at us cq.Upon visual inspection, the device was missing the ball bearing and spring components, and the device tip was bent/deformed.There was no evidence of discoloration.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: hook diameter = 2.5 +0/-0.1 mm3 measured dimensions: hook diameter = 2.50mm, conforming.Device used ¿ caliper ca215p.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the depth gauge is missing the ball bearing and spring components and has a bent tip.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.Device history.Part: 03.010.072.Lot: 8364730.Manufacturing site: hägendorf.Release to warehouse date: 07.June 2013 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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