Model Number 9505-02-055 |
Device Problems
Detachment of Device or Device Component (2907); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
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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It was reported that the sigma fixed bearing tibial punch handle is not functioning properly.The locking mechanism that holds the punch onto the handle has lost its rigidity and doesn¿t remove the punch when extracted.The punch comes off the handle.The instrument did not break, only the locking mechanism has loosened over time.No surgical delay.
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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, thus the reported event could not be confirmed.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 : 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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