BUTTRESS/COMPRESSION NUT FOR 357.369

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. 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.

Additional Manufacturer Narrative

WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2020, DURING A PROXIMAL FEMUR OSTEOSYNTHESIS USING AN INTERTROCHANTERIC NAIL, AT THE TIME OF PLACING THE SPIRAL BLADE, THE SURGEON USED THE HAMMER FOR IMPACTIONS WHICH CAUSED THE HEAD OF THE CONNECTING SCREW TO BREAK. THE SURGEON WAS UNABLE TO REMOVE THE SCREW FROM THE BLADE AND DECIDED TO REMOVE THE BLADE AGAIN BY HITTING THE INSERTION ARC. THE BLADE WAS REMOVED AND THE PROCEDURE WAS CONTINUED. THE ARCH WIRE WAS ALREADY DAMAGED BY THE IMPACTIONS. THE DRILL GUIDE WAS PLACED FOR THE DISTAL LOCKING OF THE NAIL, AND THIS HOLE THROUGH WHICH THE DRILL GUIDE SLEEVE PASSES IS NOT IN GOOD CONDITION. THE SLEEVE ENTERED THE HOLE AND THE DRILLING WAS MADE FOR THE DISTAL LOCKING OF THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) BUTTRESS/ COMPRESSION NUT FOR 357.369. THIS IS REPORT 3 OF 6 FOR (B)(4).