N
Patient 1
(B)(4). AS RETURNED, THE GRIPPER DOES NOT PROPERLY GRIP A .1185 INCH GAGE PIN IN THE 3.0MM HOLE. THE GRIPPER WOULD PROPERLY HOLD A .0945" PIN IN THE 2.4MM HOLE AND A .1185 INCH GAGE PIN IN THE 3.0MM HOLE. THE GRIPPER DOES NOT PROPERLY GRIP A .1185 INCH GAGE PIN IN THE 3.0MM HOLE WITH ONLY THE THREADED ROD BEING USED TO TIGHTEN IT. VISUAL INSPECTION CONCLUDED THERE ARE DENTS ON THE TOP AND BOTTOM SURFACES OF THE GRIPPER INDICATING PREVIOUS USE. ABRASION WAS ALSO VISIBLE ON THE 3.0MM HOLES IN THE HANDLE AND PIVOT PLATE. DAMAGE WAS ALSO NOTED TO THE TEETH. MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND DO NOT INDICATE ANY MANUFACTURING ANOMALIES. THE GUIDE WIRE GRIPPERS WERE DIMENSIONALLY ANALYZED AND FOUND TO BE WITHIN SPECIFICATION WHERE MEASURED. THE GRIPPER HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 1.5 YEARS WITH AN UNKNOWN NUMBER OF USES. THE DEVICE WAS USED FOR TREATMENT. THE DAMAGE ON THE LOCKING TEETH MIGHT HAVE CONTRIBUTED TO THE GRIPPING CONDITION. DUE TO THE DAMAGE ON THE TEETH, THE GRIPPER WAS NOT ABLE TO LOCK WHEN FULLY STRETCHED. TEETH DAMAGE MIGHT BE DUE TO WEAR AND TEAR OR EXCESSIVE FORCE APPLIED ON LOCKING NUT; HOWEVER THIS CANNOT BE CONFIRMED. ELONGATION OF THE HOLES IS PROBABLY WEAR DUE TO NORMAL USE. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.