Catalog Number 254600418 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 02/22/2019 |
Event Type
malfunction
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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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It was reported that during a total knee revision, the surgeon was broaching up to the desired femoral broach size when he was not able to extract the 35mm broach.When the surgeon attempted to remove the broach during a hit with the mallet the broach handle would disconnect from the broach.At that point the surgeon used the second broach handle in the set when he got the same result as before.Hitting the broach with the mallet during extraction of the 35mm broach would caused it the broach handle to disengaged leaving the broach in the patient.Unable to remove the broach with the broach handles the 1-3 broach adapter was threaded onto the broach then used as a hitting surface for the mallet to get the broach out.As a result the 3-1 broach adapter needs to be replaced because it was bent from removing the 35mm broach.No pieces of the instruments broke off during the procedure , therefore, no pieces had to be retrieved.All parts are being sent back to depuy.Surgery prolonged 10 min.
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Manufacturer Narrative
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Product complaint # (b)(4).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.Added: concomitant medical products.Corrected: device evaluated by mfr.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 provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : the device was reviewed by bioengineering and confirmed it was unlikely that a manufacturing defect was present.Root cause undetermined.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 will be filed as appropriate.
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Search Alerts/Recalls
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