Model Number N/A |
Device Problems
Detachment Of Device Component (1104); Fracture (1260); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
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Event Description
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It was reported a patient underwent an internal fixation procedure on (b)(6) 2015.During the procedure, the drill bit froze and locked into the plate, resulting in the drill bit fracturing off into the plate.The plate and screws were removed and a new plate was used to complete the procedure.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Root cause of the event was most likely attributed to surgical technique.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, "intraoperative fracture or breaking of instruments has been reported for general instruments." under care and handling of instruments, it states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported a patient underwent an internal fixation procedure on (b)(6) 2015.During the procedure, the drill bit froze and locked into the plate, resulting in the drill bit fracturing off into the plate.The plate and screws were removed and a new plate was used to complete the procedure.There was a one hour delay in procedure.
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Search Alerts/Recalls
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