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Catalog Number 414.860S |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
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.Additional narrative: additional device product codes: ktt, hrs.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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Event Description
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Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2022, the surgeon used a single 60 mm, 4.5 cortex screw from a sterile box in two different cases.In both instances it turned out that the screw was slightly bent.This was concerning as they were from the same lot number.There was no surgical delay as a result of this event.The surgeon used a different screw to successfully complete the procedure.There was no patient consequence.This report involves one 4.5mm ti cortex screw self-tapping 60mm.This is report 2 of 2 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 414.860s lot # 9l29175 manufacturing site: werk selzach release to warehouse date: 22.Apr.2022 expiration date: 01.Apr.2032 supplier: (b)(4).A manufacturing record evaluation was performed for the non sterile article lot and no non-conformances were identified.Part # 414.860 lot # 757p190 manufacturing site: grenchen release to warehouse date: 05.Apr.2022.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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