Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n: 319.006, lot #: ft00443) was returned and received at us cq.Upon visual inspection, it was observed that the needle component was broken and the broken fragment was not returned.No other issues were identified.The reported condition of missing components could not be confirmed as the device is broken and all the remaining components are returned.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: the relevant documents were reviewed: no design issues or discrepancies were identified.Investigation conclusion: the complaint condition was confirmed as the needle component of the depth gauge was broken.No definitive root cause could be determined based on the provided information.The unintended forces might have contributed to the reported complaint condition.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.A device history record (dhr) review was conducted: part # 319.006.Synthes lot # ft00443.Release to warehouse date: 15 may 2017.Supplier: flextronics america, llc.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 an unknown date during the cleaning process prior to sterilization, depth gauge broke.No patient involvement.Another depth gauge (part # 319.006, lot #: ft00443) was returned to manufacturer under this complaint.During manufacturer's investigation of the returned device it was identified that the needle component of the depth gauge was broken and the broken fragment was not returned.This product condition was evaluated and determined to be reportable on (b)(6) 2021.This report is for (1) depth gauge for 2.0mm and 2.4mm screws.This report is 2 of 2 (b)(4).
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