Model Number N/A |
Device Problems
Component Falling (1105); Fracture (1260)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 09/08/2015 |
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.Review of device history records show that lot released with no recorded anomaly or deviation.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.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.¿.
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Event Description
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It was reported that patient underwent a total shoulder arthroplasty on (b)(6) 2015.During the procedure, the glenoid poly impactor fractured while inserting the poly.A piece fell into the patient and was retrieved.Another poly impactor 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 additional information, which was unknown at the time of the initial medwatch.
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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.Product left conforming to print as there was no evidence that states otherwise.Visual review shows the side of the impactor head fractured and fractured off.Instrument fracture most likely occurred due to incorrect alignment.Based on these results the complaint is considered confirmed.
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Search Alerts/Recalls
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