CURVED LATERAL OSTEOTOME 14

Additional Manufacturer Narrative

PRODUCT COMPLAINT: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. ADDED: D1.

Description of Event or Problem

IT WAS REPORTED THAT CURVED LATERAL OSTEOTOME 14 AND STRAIGHT MEDIAL OSTEOTOME 14 WERE INVOLVED IN AN EVENT. DURING AN ATTEMPT TO REMOVE AN INFECTED FEMORAL STEM USING WATSON EXTRACTOR INSTRUMENTS, THE CONNECTION PART OF THE CURVED LATERAL OSTEOTOME 14 BLADE BROKE OFF AND BECAME LODGED IN THE FEMUR, REQUIRING ADDITIONAL TOOLS FOR REMOVAL. THE STRAIGHT MEDIAL OSTEOTOME 14 BLADE BENT AND WAS RENDERED UNUSABLE. THE STEM COULD NOT BE REMOVED WITH THE WATSON INSTRUMENTS, NECESSITATING AN EXTENDED TROCHANTERIC OSTEOTOMY (ETO) TO EXTRACT THE STEM, WHICH PROLONGED THE SURGICAL PROCEDURE. THERE WAS NO INDICATION THAT THE INSTRUMENT MALFUNCTIONS OR SURGICAL DELAYS RESULTED IN ANY DIRECT IMPACT TO THE SURGICAL OUTCOME OR CAUSED ANY PATIENT CONSEQUENCE OR INJURY.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.