STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 0227-6100 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that im reamers broke during use.
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Manufacturer Narrative
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Correction: please refer to h6 clinical code, h6 health impact code.The reported event could be confirmed, since the device returned and matches the reported failure mode.The device inspection revealed the following: the im reamer was received in which the distal end of the reamer started to unwind which can be due to the movement of the reamer in the counterclockwise direction.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to improper usage of the reamer as it was operated in an anti-clockwise manner which is an off-label use if the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that im reamers broke during use.
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Search Alerts/Recalls
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