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 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.?
D
Patient 1
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE SURGEON USED A MALLET TO IMPACT THE HANDLE ON THE STRIKE PLATE. UPON IMPACTION, THE THREADS OF THE SCREW HOLE WERE DAMAGED. IN AN ATTEMPT TO REMOVE THE HANDLE, THE HANDLE FRACTURED. IT IS UNKNOWN IF PIECES HAD TO BE RETRIEVED FROM PATIENT.
N
Patient 1
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.