Model Number 1826-1036S |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was implanted.
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Event Description
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As reported: "styrofoam scrapes was in the nail screw holes in a sterile package when the package of the nail was opened during the operation.The procedure continued without exchanging the product after it was cleaned.".
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿inspection is recommended prior to surgery to determine if instruments or implants have been damaged during storage or prior procedures.'¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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As reported: "styrofoam scrapes was in the nail screw holes in a sterile package when the package of the nail was opened during the operation.The procedure continued without exchanging the product after it was cleaned.".
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Search Alerts/Recalls
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