Model Number 2544-00-520 |
Device Problems
Use of Device Problem (1670); Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/31/2021 |
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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It was reported that on (b)(6) 2021, the patient underwent tka for ra.During the surgery, it was found that there was no metal ring before the surgeon inserted the temporary fixation pin.After the surgery, the surgeon and nurse checked the case and the cardboard box at the time of delivery, but found no metal ring.After the surgery, no metal ring was confirmed on x-ray.The surgeon and nurse also looked for an operating room, but could not find it.The surgery was completed successfully and there was less than 30 min surgical delay.No further information is available.
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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 : examination of the returned device revealed one of the metal bushings was dislodged and missing.Root cause and corrective action are documented in the capa system.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 (mre) was not performed.
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Search Alerts/Recalls
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