Model Number DYNANITE NITI STAPLE W/INSTRS 18WX18/15L |
Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/02/2022 |
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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On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8771-0422x dynamite compression plate was implanted on patient during a tarsal metatarsal fusion procedure on (b)(6) 2021.On (b)(6) 2022, it was noticed to be broken via x-ray.Patient underwent tarsal metatarsal fusion revision surgery on (b)(6) 2022 and had the ar-8771-0422x dynamite compression plate along with the staples from an ar-8719ds-181815 dynamite nitinol staple implant system removed.Surgeon completed the revision surgery by implanting devices from another manufacturer.Case was completed successfully and no further issues has been reported.
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Manufacturer Narrative
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Complaint not confirmed.Upon visual inspection, it was noted that there was damage/tool marks to the top of the staple.No other problems were noted with the device.The cause remains undetermined however, a likely cause is contributed to the removal process of the staple.
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Search Alerts/Recalls
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