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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 02/19/2024 |
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.E3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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Device report from synthes reports an event in the united kingdom as follows: it was reported that on february 19, 2024, the items were broken.There was no harm caused to the patient.There was no delay in surgery time.This report is for one (1) aiming arm/ radiolucent this is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: product code: 03.043.029; lot number: 2025454; release to warehouse date: 01.Jul.2021; expiration date: na; supplier: createc gmbh & co.Kg; manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual analysis of the returned sample revealed that the device had no damage or broken fragments.Therefore the broken allegation cannot be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was preformed, the spring of the latch was active and it feels like a vibration in the latch also a noise was made for the friction in the internal mechanism of the spring.The device fail the functional test.The overall complaint was unconfirmed as the observed condition of the aim-arm radioluc would not contribute to the complained device issue.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.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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