Model Number 2217-50-041 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
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.Investigation summary: a blind device with no information or any allegation was received.Examination of the returned device found the impaction end broke off the handle.The overall condition of the instrument shows normal wear consistent with the device use.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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(b)(6) impactor with a broken handle was received on (b)(6) /2021 by a complaint analyst as a blind unit.There were no allegations associated with the receipt of the device.No further information is available.
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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.Investigation summary: a blind device with no information or any allegation was received.Examination of the returned device found the impaction end broke off the handle.The overall condition of the instrument shows normal wear consistent with the device use.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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Pinnacle impactor with a broken handle was received on (b)(6) 2021 by a complaint analyst as a blind unit.There were no allegations associated with the receipt of the device.No further information is available.
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Search Alerts/Recalls
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