Zimmer biomet complaint: (b)(4).Report source (b)(6).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.Based on dhrs, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.The acetabular inserter¿s screw hole was deformed and the handle and its threads had fractured as stated in the complaint.The screw hole threads were tested and thread gauge was only able to thread into the hole about a quarter turn at most as the hole was deformed due to repeated impactor blows.The handle of the inserter most likely fractured due to repeated mallet blows to the side of the handle body as the surgeon was attempting to remove the handle.The fractured threads most likely fractured from the same mallet blows to the side of the handle as the fracture appears consistent with bending overload.The complaint states that the instrument has been used several times and may have been damaged previously which could have led to the failure in this procedure.Inspection of the instrument prior to the procedure may have prevented this failure.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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It was reported during a total hip arthroplasty, that the screw hole's threads were deformed after impacting the strike plate with the mallet.This made it not possible to assemble the slap hammer to the inserter.To remove the handle, the surgeon hit the bottom of the handle with the mallet and fractured the handle.In the process, the distal tip of the inserter also fractured.No fractured pieces fell into the patient.No adverse events have been reported as a result of the malfunction.
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