SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/2H SHAFT/RT; PLATE, FIXATION, BONE
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Model Number 04.111.620 |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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.Unknown event date.Complainant part is not expected to be returned for manufacturer.Review/investigation.Reporter telephone (b)(6).No code available is for injury/revision surgery.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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Device report from synthes reports an event in france as follows: the patient was hospitalized on (b)(6) 2022 for a fracture of the distal radius reduced by osteosynthesis.The exact implant date is unknown.The patient was re-examined after one month and presented with unscrewing of the implants placed as well as breakage of the 4 distal epiphyseal locking screws at the body-head junction in the absence of a fall.Additionally secondary displacement of the fracture site with extra-articular callus occurred.The material initially implanted was removed during a surgery revision on
(b)(6) 2022 to rectify the callus and new osteosynthesis by plate.This is report 5 of 9 for (b)(4).This report is for a distal radius plate.
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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: d4, d9 h3, h4, h6: part 04.111.620, lot 69p8249: manufacturing site: mezzovico.Release to warehouse date: september 12, 2020.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the plate exhibits signs of normal use.Four broken locking screw fragments remain attached to the distal end of the plate.No significant product problem was observed.A dimensional inspection was unable to be performed due to being irrelevant for the complaint condition.Migration of the device cannot be assessed since no postoperative images were provided.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition would not 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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.
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Search Alerts/Recalls
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