Model Number 2546-00-424 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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During attune revision surgery the femoral sleeve impactor became stuck on the femoral sleeve and had to be removed with a vice grip and slap hammer.This damaged the distal part of the sleeve and the surgeon was not happy to implant.He used a fully coated femoral sleeve (instead of distally coated which was opened and was his preference).This instrument is used for both tibial and femoral sleeve impaction so each end is impacted with a mallet which appears to be deforming the instrument.Surgical delay of 10 minutes occurred.No adverse affects on the patient.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this complaint was received for examination.The photo investigation and visual examination found the device heavily nicked, scratched and the device is beginning to deform, confirming the reported allegation for the damage.However the device was received without any mating component jammed, the photographs show 1 picture of the device attached, but with the evidence provided the investigation cannot confirm the reported allegation for jammed.No device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mrae) was not performed.
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Search Alerts/Recalls
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