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Catalog Number 03.043.029 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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: d2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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It was reported that on (b)(6) 2023, during a tibial nail advanced case, the aiming arm hooks that latch on to the insertion handle broke off.The screws had already been inserted so there was no longer a need for the aiming arm, thus the case was able to proceed and be completed.There was no surgical delay.The procedure was completed successfully.All fragments were removed easily without medical intervention.It was unknown if there were any patient consequences.Concomitant product details: unk - screws: trauma (part # unknown, lot # unknown, qty - unknown), unk - nail insertion handles (part # unknown, lot # unknown, qty - unknown), unk - nails: tibial (part # unknown, lot # unknown, qty - unknown).This report is for one (1) aiming arm/ radiolucent.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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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.H3, h4, h6 investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the aim-arm radioluc [03.043.029/2024220] had both of the hooks of the latch broken, fragments were not returned.No other issues were found.The device has signs of normal use/wear and no evidence of hammer marks were observed, therefore, a potential cause cannot be established with the provided information due to be a multifactorial issue.The semi-extended parapatellar approach surgical technique guide was reviewed.Following relevant statements were found.Precautions: -ensure that the connection between the nail and the insertion handle is tight.Retighten if necessary, after hammering and prior to the attachment of the aiming arm.-do not attach the aiming arm to the insertion handle at this point.-do not exert forces on the aiming arm.These forces may prevent breakage of the device.Based on the investigation findings, the primary cause was related to the users hammering with the aiming arm in place or actually hitting on the aiming arm.A dimensional inspection for the aim-arm radioluc [03.043.029/2024220] was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aim-arm radioluc [03.043.029/2024220] would contribute to the complained device issue and hence the root cause cannot be determined.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history part:03.043.029, lot:2024220, manufacturing site: werk selzach, supplier:(b)(4), release to warehouse date: 15 feb 2021, expiration date: na.A manufacturing record evaluation was performed for the finished article lot 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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Search Alerts/Recalls
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