SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.124.412 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/23/2023 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in taiwan as follows: it was reported that on an unknown date, one month after the initial operation, the patient returned for an x-ray and found that the implanted plate was broken.Intervention was required as a result of the event.No further information is available.This report involves one 4.5mm va-lcp curved condylar plate/12 hole/266mm/right.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: only the event year is known.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.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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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, h6: 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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Event Description
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It was further reported that the revision procedure occurred on (b)(6) 2023.The procedure was completed successfully.Patient status was good.Patient was originally treated on (b)(6) 2023.
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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 va-lcp condylar plate 4.5/5.0 r 12ho l26 was found broken across to one of the locking holes, scratches were observed in the fracture.Both fragments were received for evaluation.A dimensional inspection for the va-lcp condylar plate 4.5/5.0 r 12ho l26 was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the va-lcp condylar plate 4.5/5.0 r 12ho l26 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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.Drawing/specifications reviewed? reviewed dimensional inspection: n/a device history part number: 02.124.412, lot number: 4840p65, manufacturing site: mezzovico, release to warehouse date: 20 mar 2023.A manufacturing record evaluation was performed for the not sterile finished 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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