ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Model Number Ø8X 20MM BC IF SCRW, VENTED |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an anterior cruciate ligament knee arthroscopy the device broke during placement in the tibia to fix the acl graft.One piece of the broken device remained in the patient and the other piece could be recovered.No second surgery is planned to remove the broken part.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.
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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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Manufacturer Narrative
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Complaint confirmed.Upon visual inspection, it was noted that one device was broken into 3 pieces and the other was cracked.Measurements could not be taken due to the damaged state of the device.The cause of this remains undetermined, however probable cause can be attributed to prying or leveraging forces being applied during insertion.
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Search Alerts/Recalls
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