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Model Number SUTURE ANCHOR, CORKSCREW FT |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during a surgery the handle of the device was broken.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 10-dec-2021: it was confirmed that at first the wrong information was provided with the complaint.The anchor broke during insertion.Part of the anchor broke off during inserted into the patient.The broken pieces were retrieved from the patient.
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Manufacturer Narrative
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Complaint confirmed, the driver tip broke off.No fragment was returned.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during insertion.
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Search Alerts/Recalls
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