ENDPLATE ELEVATOR 20MM WIDTH

Additional Manufacturer Narrative

SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT LUMBAR SPINE DISC L4-S1 WITH SYNFIX EVOLUTION SYSTEM ON (B)(6) 2018. DURING THE PROCEDURE, WHEN THE SURGEON WAS PREPARING THE DISC SITE UPON THE REMOVAL OF THE DISC, THE ENDPLATE ELEVATOR COBB HANDLE APPEARED TO ROTATE UPON ITSELF. THERE WAS A PIN IN THE HANDLE THAT WAS ALSO VISIBLE BUT DID NOT APPEAR TO BE LOOSE. THE SURGEON THEN APPLIED PRESSURE, UNTIL THE HANDLE WAS FIRM, BUT THE INSTRUMENT WAS STICKING AND DID NOT MOVE FREELY OR SPRING BACK. A KERRISON (4 MM) DEVICE WAS USED TO REMOVE THE DISC MATERIAL AND COMPLETE THE SURGICAL PROCEDURE. THERE WAS MINIMAL DELAY TO THE SURGERY. THIS REPORT IS FOR ONE (1) ENDPLATE ELEVATOR 20 MM WIDTH. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT LUMBAR SPINE DISC L4-S1 WITH SYNFIX EVOLUTION SYSTEM ON (B)(6) 2018. DURING THE PROCEDURE WHEN THE SURGEON WAS PREPARING THE DISC SITE UPON THE REMOVAL OF THE DISC. THE ELEVATOR COBB HANDLE APPEARED TO ROTATE UPON ITSELF. THERE IS A PIN IN THE HANDLE THAT IS VISIBLE AND AFTER HE HAD APPLIED PRESSURE, THE HANDLE WAS FIRM AGAIN. THE PIN DID NOT APPEAR TO BE LOOSE. A (4MM) KERRISON WAS USED TO REMOVE THE DISC MATERIAL AND THE INSTRUMENT WAS STICKING, IT DID NOT MOVE FREELY OR SPRING BACK, AFTER IT WAS SQUEEZED. THERE WAS A MINIMAL DELAY TO THE SURGERY. THE SURGEON USED OTHER INSTRUMENTS TO COMPLETE THE SURGERY.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 389.550, LOT: AQ31567. MANUFACTURING LOCATION: HÄGENDORF, RELEASE TO WAREHOUSE DATE: (B)(6) 2007. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: PRODUCT INVESTIGATION WAS COMPLETED. THE DEVICE WAS FOUND IN A USED CONDITION. THE PIN PROTRUDES APPROXIMATELY 1MM OUT OF THE HANDLE MADE OF MATERIAL CANEVASIT. THE RETURNED DEVICE WAS TESTED AND THE COMPLAINT CONDITION COULD BE CONFIRMED, AS THE HANDLE IS MOVABLE/ LOOSE. INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS CONFIRMED. THE EXACT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. DUE TO THE WEAR AND TEAR SIGNS, IT CAN BE ASSUMED THAT THIS PRODUCT WAS OFTEN AND INTENSIVE USED INSTRUMENT OVER THE YEARS. IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DROPPED OR A MECHANICAL OVERLOAD) WHICH HAVE CONTRIBUTED TO THE LOOSENING OF THE PIN AND THE MALFUNCTION OF THE DEVICE AS RESULT. AS PER THE LEAFLET ¿IMPORTANT INFORMATION¿: END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. H11 CORRECTED DATA: B5, E1: REPORTER FACILITY ADDRESS. G1. 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.