SIGMA HP UNI AP KEEL OSTEOTOME

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE, HEALTH EFFECT - CLINICAL CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. B. PLEASE VERIFY IF THERE WAS ANY ADVERSE EVENT/PATIENT HARM INVOLVED? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. C. WHAT DO YOU MEAN BY DAMAGED FOR THE PRODUCT CODES: 202440100 AND 202440200? 202440100 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440100 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440200 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK RM/LL - CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL ALL ITEMS ABOVE HAVE A CUTTING SLOT ¿ WHERE THE SAW BLADE HAS REPEATEDLY HIT THIS DURING SURGERY IT HAD WARPED THE METAL CAUSING DAMAGE AND THE SAW BLADE NO LONGER CAN FIT THROUGH THE CUTTING SLOT. ALL ITEMS ARE STILL IN ONE PIECE.

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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6 INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE ITEMS WERE DAMAGED. ISSUES DID NOT OCCUR DURING SURGERY. SIGMA HP UNI TIB CUT BLK LM/RL (X2) ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY. SIGMA HP UNI TIB CUT BLK RM/LL - CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY. SIGMA HP UNI ANTERIOR CHISEL ¿ CHISEL END SNAPPED INTO TWO PIECES, PIECES BOTH DISPOSED OF. SIGMA HP UNI AP KEEL OSTEOTOME ¿ METAL KEEL END BENT, NO LONGER FIT FOR USE. SIGMA HP UNI FB KEEL OSTEOTOME - METAL KEEL END BENT, NO LONGER FIT FOR USE