Model Number 1806-3211 |
Device Problem
Residue After Decontamination (2325)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/26/2022 |
Event Type
Injury
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Event Description
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As reported: "at the start of the medical procedure in this clinic, the bloody nail holding screw 1806-3203 (loaner) from the last surgery of the previous patient was still in the nail holding adapter 1806-3211.This was overlooked during the kit inspection, and a new nail holding screw was added instead.The instrument set was therefore hygienically not ok and could not be used for the surgery.Patient received unnecessary anesthesia.The surgery was cancelled and will be made up on monday (b)(6) 2022 under sterile hygienic conditions." additionally, it was reported; the procedure was extended however the length of the extension is unknown.
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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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Manufacturer Narrative
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The reported event could not be confirmed, since the device was returned but does not match the alleged failure.The received nail adapter shows no sign of any blood/dirt residue on the surface, usage marks are visible.The further device looks in good condition.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.However, a local nc has been initiated to address the failure mode related to this complaint.If any additional information is provided, the investigation will be reassessed.
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Event Description
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As reported: "at the start of the medical procedure in this clinic, the bloody nail holding screw 1806-3203 (loaner) from the last surgery of the previous patient was still in the nail holding adapter 1806-3211.This was overlooked during the kit inspection, and a new nail holding screw was added instead.The instrument set was therefore hygienically not ok and could not be used for the surgery.Patient received unnecessary anesthesia.The surgery was cancelled and will be made up on monday 8/29/22 under sterile hygienic conditions." additionally, it was reported; the procedure was extended however the length of the extension is unknown.
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Search Alerts/Recalls
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