Catalog Number 217863136 |
Device Problems
Loose or Intermittent Connection (1371); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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Product code : 217863136.Lot/batch/exp: unknown.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? reamer removed with jacobs chuck.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? less than 30 min delay.Impact: compromised reaming diameter.Surgery was completed ok.Has the reporter facility indicated there may be legal action? no.Is the product available for return? it will be once received from external sterile services.Please give a detailed explanation of the event: reamer was used with the t-handle and adaptor.Adapter started slipping / not gripping.This resulted in the reamer being stuck in the femur.Reamer removed with powertool and jacobs chuck.Surgeon could not perform further reaming as there were no other alternatives available.Surgeon judged that this would be sufficient to proceed.Surgery completed ok and in good time.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).
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Manufacturer Narrative
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Product complaint # : (b)(4).The device was returned and confirmed it was worn.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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