Model Number 2440-00-548 |
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 03/22/2021 |
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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Surgeon has indicated several common acetabular grater head reamers in multiple sets (4 each of sizes 47mm-57mm) are dull and worn down due to normal wear and tear (reaming) over an extended period of time and no longer cut into the bone as efficiently.No surgical delay or patient issues.Surgeries all completed successfully.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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