HPUNI FEM FINISH BLK SZ5 LMRL

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 THAT 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: D9. CORRECTED: E1 FACILITY NAME. 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

THE HP UNI FEMORAL CHISEL WAS INTRODUCED IN THE HP UNI FEM FINISH BLK SZ5 LMRL THE WRONG WAY (THE ¿ANT¿ AND TWO LINES FACING DOWNWARDS) WHICH LED TO THE CHISEL BEING STUCK IN THE ANTERIOR CHAMFER SLOT AND THE BLOCK BROKE INTO TWO ON THE MEDIAL SIDE, JUST BELOW THE MEDIAL PIN HOLE.

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.

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 THAT 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: 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 STATES THAT THE HP UNI FEM FINISH BLK SZ5 LMRL HAS ONE BROKEN FRAGMENT THAT IS STUCK ON THE MATING COMPONENT. THE HP UNI FEMORAL CHISEL IS ALSO ONE STUCK ON THE MATING COMPONENT.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE HP UNI FEMORAL CHISEL WAS INTRODUCED IN THE HP UNI FEM FINISH BLK SZ5 LMRL THE WRONG WAY (THE ¿ANT¿ AND TWO LINES FACING DOWNWARDS) WHICH LED TO THE CHISEL BEING STUCK IN THE ANTERIOR CHAMFER SLOT AND THE BLOCK BROKE INTO TWO ON THE MEDIAL SIDE, JUST BELOW THE MEDIAL PIN HOLE. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE HPUNI FEM FINISH BLK SZ5 LMRL WAS RETURNED BROKEN INTO TWO PIECES, ALL PIECES WERE RETURNED. ONE OF THE BROKEN PIECES WAS FOUND TO BE ASSEMBLED TO THE HPUNI FEMORAL CHISEL. DEVICE ALSO DISPLAYS SINGS OF REPETITIVE USE. FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO DISASSEMBLE THE HPUNI FEMORAL CHISEL FROM THE HPUNI FEM FINISH BLK SZ5 LMRL, HOWEVER THEY WERE FOUND TO BE JAMMED DUE TO THE ORIENTATION IN WHICH THE HPUNI FEMORAL CHISEL WAS INTRODUCED TO THE HPUNI FEM FINISH BLK SZ5 LMRL. BASED ON THE EVENT REPORTED AND IN THE CONDITION IN WHICH THE DEVICE WAS RETURNED, THE POTENTIAL CAUSE IS TRACED TO USER, THE HPUNI FEMORAL CHISEL WAS INTRODUCE IN A WRONG ORIENTATION TO THE HPUNI FEM FINISH BLK SZ5 LMRL, THEREFORE THIS CAN LEAD WITH BOTH DEVICES FAILURE/DAMAGE. AS PER THE SURGICAL TECHNIQUE INTUITION¿ INSTRUMENTS FOR SIGMA¿ HP PARTIAL UNICONDYLAR KNEE REPLACEMENT 227024-230316 (PAGE 22); PLACE THE CHISEL IN THE ¿T¿ SLOT OF THE BLOCK TO PREPARE THE ANTERIOR CHAMFER. TAP UNTIL THE MECHANICAL STOP IS REACHED IN THE BLOCK. THE CHEVRON MARKINGS ON THE CHISEL SHOULD NOT BE VISIBLE WHEN IT IS SEATED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HPUNI FEM FINISH BLK SZ5 LMRL WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. CORRECTED: H3.