Udi is unknown.Complainant part is expected to be returned for manufacturer review / investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 a routine inspection on (b)(6) 2019, a depth gauge was found broken inside a modular hand set.There were no patient and surgical involvement.Concomitant device reported: unknown modular hand set (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) depth gauge for 1.3 mm and 1.5 mm screws.This is report 1 of 1 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.Part: 319.004.Lot: 4812294.Part manufacture date: july 21, 2004.Manufacturing location: brandywine.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the depth gauge was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.The product lot met all assembly, laser etch, inspection, and packaging criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Visual investigation: the depth gauge for 1.3mm and 1.5mm screws was received for investigation at us customer quality on november 12, 2019.Visual inspection of the complaint device shows the depth gauge needle has broken off of the main body.All components of the device are present.Dimensional inspection: no dimensional inspection will be performed due to post manufacturing damage.Document/specification review: manufactured and current drawing revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the depth gauge is broken.No definitive 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 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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