Model Number 2544-00-522 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
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 an unknown drill pin won't go through the holes of an attune distal femoral cutting block.There was no surgical delay reported.
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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.H10 additional narrative: added: h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = examination of the returned device was unable to replicate the reported event.No evidence of product malfunction or product error was found and the investigation did not indicate that a broader investigation or corrective action was necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Retracting the reported expiration date in d4 since the product involved was an instrument.Instruments do not have expiration dates.
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Search Alerts/Recalls
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