Model Number 212760 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2022 |
Event Type
Injury
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Event Description
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It was reported that the offset reamer handle screw came off and was left in the patient."we had a patient that needed to have a second surgery to remove a screw that was left behind in the hip.After inspecting the reamer handle we noticed that a screw was missing.Today after inspecting another reamer handle my colleague noticed that also in that one screws are missing".
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Manufacturer Narrative
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Reported event: the end user reported that the offset reamer handle screwed off.Product evaluation and results: product inspection could not be performed as the product was not returned for evaluation.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock without any discrepancies.Complaint history review: a review of complaints shows 0 additional complaints related to the failure in this investigation.Conclusion: the failure could not be determined as the product was not returned for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Manufacturer Narrative
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Reported event: it was reported that the offset reamer handle screw came off and was left in the patient.Product evaluation and results: an image of the device has been provided, the alleged failure of the disassociated screw can be determined however the product was not evaluated as the product was unavailable for inspection.If additional information is received, then the complaint will be reopened.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock without any discrepancies.Complaint history review: a review of complaints shows 0 additional complaints related to the failure in this investigation.Conclusion: the failure could be determined via inspection of the image provided however the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Event Description
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It was reported that the offset reamer handle screw came off and was left in the patient."we had a patient that needed to have a second surgery to remove a screw that was left behind in the hip.After inspecting the reamer handle we noticed that a screw was missing.Today after inspecting another reamer handle my colleague noticed that also in that one screws are missing".
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Search Alerts/Recalls
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