(B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW FOR PART #388.63, SYNTHES LOT #4547325. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 26-FEB-2003. MANUFACTURED BY SYNTHES (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A T4-L2 SCOLIOSIS PROCEDURE ON (B)(6) 2017. DURING THE PROCEDURE, A HOOK POSITIONER HAD A CHUNK COME OUT OF THE PHENOLIC HANDLE DURING MALLETING. THE CHUNK WAS RECOVERED EASILY. LATER, A SOCKET WRENCH WITH STRAIGHT HANDLE SPLIT INTO TWO PIECES DURING MALLETING. ALL PIECES WERE RECOVERED. FINALLY, UPON FINAL TIGHTENING, THE SURGEON NOTICED THAT A TITANIUM (TI) COLLAR WITH GROOVES AT T8 LEFT WAS BROKEN TOWARD THE END OF THE PROCEDURE. THE BROKEN DEVICE WAS EASILY AND QUICKLY REMOVED AND ANOTHER COLLAR WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: TITANIUM NUT 11MM WIDTH ACROSS FLATS (PART 498.003, LOT NUMBER UNKNOWN, QUANTITY 1); 5.0MM TITANIUM SIDE-OPENING SCREW 35MM (PART 498.535, LOT NUMBER UNKNOWN, QUANTITY 1); MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOOK POSITIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).