Occupation: reporter is a j&j employee.A product investigation was conducted.Visual inspection: the depth gauge for 2.0 mm and 2.4 mm screws (part #: 319.006, lot #: 5682849) was received at us cq.Upon visual inspection, it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base.No other issues were identified.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage and device geometry.Document/specification review: the relevant drawing(s) were reviewed: no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the complaint device was missing the protection sleeve component and the tip of the device was bent at the proximal base.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use and/or the missing components of the device were displaced when taken apart for sterilization.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 # 5682849, supplier lot # n/a, release to warehouse date: 18 jan 2008, manufactured by synthes (b)(4).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.
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It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge was missing a piece.There was no known patient or hospital involvement.During manufacturer's investigation of the returned device it was observed that the device was missing the protection sleeve component and the tip of the device had bent at the proximal base.This product condition was re-evaluated and found to be reportable on (b)(6) 2020.This report is for one (1) depth gauge for 2.0 mm and 2.4 mm screws.This is report 1 of 1 for (b)(4).
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