N
Patient 1
(B)(4). THE RETURNED DEVICE EXHIBITS WEAR AND TEAR THAT INDICATES USE. A FUNCTIONAL TEST WAS PERFORMED USING 2.5MM AND 3.0MM SMOOTH GUIDE WIRES. THE DEVICE FUNCTIONED AS INTENDED BY HOLDING SUFFICIENTLY BOTH THE 2.5MM AND 3MM WIRES. THERE IS SOME DAMAGE NOTED AROUND THE 3.0MM HOLE AS WELL AS ON THE THREAD OF THE THREADED ROD. THE PRODUCT WAS MEASURED AGAINST THE PRINT SPECIFICATIONS AT SEVERAL DIMENSIONS AND IT WAS CONFIRMED THAT ALL MEASUREMENTS TAKEN WERE WITHIN SPECIFICATION. DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS INDICATED THAT THE DEVICE MET SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE GUIDE WIRE GRIPPER HAD A POTENTIAL FIELD AGE OF APPROXIMATELY 5 YEARS AND 3 MONTHS AT THE TIME OF INCIDENT. THE DEVICE IS USED FOR TREATMENT. THE PACKAGE INSERT INCLUDED SPECIFIES THAT THE DEVICE MAY NOT PERFORM AS INTENDED IF DAMAGED OR WORN. ALTHOUGH THE DEVICE PASSED THE FUNCTIONALITY TEST, THE GUIDE WIRE GRIPPER HAVING WEAR DAMAGE ON THE THREADS AND AROUND THE 3MM HOLE HAS POTENTIAL TO COMPROMISE THE FUNCTION OF THE DEVICE; THEREFORE, THE MOST LIKELY CAUSE OF THE INSTRUMENT NOT GRIPPING IS WEAR AND TEAR FROM USE. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.