Model Number 2440-00-554 |
Device Problems
Failure to Cut (2587); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2021 |
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 the reamers became dull.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will 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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Event Description
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A.Alert date -a.(b)(6)21 b.Event date -b.(b)(6)21 c.Was there surgical delay? -c.No d.What was the duration of delay? -d.No e.Please provide valid lot code for the following: 1.49mm(244000549), quickset ace grater head 2.53mm(244000553), quickset ace grater head 3.54mm(244000554), quickset ace grater head 4.56mm(244000556), quickset ace grater head 5.57mm(244000557), quickset ace grater head -e.All worn off".
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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: b5 and h6 (device) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.
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Search Alerts/Recalls
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