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Patient 1
DENTS AND SCRATCHING ARE VISIBLE ON THE TOP AND BOTTOM STRIKING SURFACES OF THE GRIPPER INDICATING PREVIOUS EFFECTIVE USE. SLIGHT ABRASION WAS OBSERVED AROUND THE GUIDE WIRE HOLES ON THE DEVICE. DAMAGE WAS ALSO NOTED TO THE THREADS OF THE THREADED ROD. DAMAGE WAS NOTED TO THE LOCKING TEETH. PREVIOUS REVIEW OF MANUFACTURING RECORDS INDICATED THE DEVICE WAS CONFORMING TO SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE GUIDE WIRE GRIPPERS WERE FOUND TO BE WITHIN SPECIFICATION WHERE MEASURED. THIS DEVICE IS USED FOR PATIENT TREATMENT. THE DAMAGE ON THE LOCKING TEETH MAY HAVE CONTRIBUTED TO THE GUIDE WIRE SLIDING THROUGH THE HOLES, AS EXHIBITED DURING THE FUNCTIONALITY TEST. THE PROBABLE CAUSE FOR THE ELONGATION OF GUIDE WIRE HOLE FEATURE IS LIKELY WEAR DUE TO NORMAL USE AND TEETH DAMAGE MIGHT BE DUE TO WEAR AND TEAR OR EXCESSIVE FORCE APPLIED ON LOCKING NUT; HOWEVER THIS CANNOT BE CONFIRMED WITH AVAILABLE INFORMATION. THE GRIPPER HAS A POTENTIAL FIELD AGE OF APPROXIMATELY FOUR YEARS WITH AN UNKNOWN NUMBER OF USES. THE DEVICE HAS REACHED THE END OF ITS USEFUL LIFE. DUE TO PREVIOUS REPORTS, A NEW DESIGN WAS RELEASED TO INCREASE THE HARDNESS OF THE STRIKE PLATE AND TIGHTEN TOLERANCE OF THE GUIDE WIRE HOLE. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.