5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/50MM

Description of Event or Problem

MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, AN X-RAY OF FEMUR REPORT AND REVEALED A CLOSED COMMINUTED SUPRACONDYLAR FRACTURE OF LEFT FEMUR WITH NONUNION. DOI: ON (B)(6) 2019; DOE: ON (B)(6) 2020; LEFT FEMUR. THIS REPORT IS FOR A 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/50MM. THIS IS REPORT 4 OF 14 FOR (B)(4).

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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PROCODES: HRS, HWC. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: DATE OF CONCOMITANT THERAPY IS (B)(6) 2019. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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.