SIGMA HP UNI FB KEEL OSTEOTOME

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: WHEN USING THE TIBIAL OSTEOTOME TO REMOVE THE BONE FROM THE KEEL SLOT THE METAL BUTTON AT THE END OF THE OSTEOTOME CAME LOOSE BECAUSE OF A HAMMER BLOW. WHEN REMOVING THE OSTEOTOME THE WHOLE INSTRUMENT FELL APART. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SIGMA HP UNI FB KEEL OSTEOTOME WAS BROKEN FROM THE END CAP THAT SECURES THE CAP TO THE SHAFT. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO EXCESSIVE FORCES AND UNINTENDED IMPACTIONS. ADDITIONALLY THE DEVICE PRESENTS SIGNS OF WEAR AND DEFORMATION AT THE TIP, CONSISTENT THROUGH THE 10 YEARS OF SERVICE. THE OBSERVED CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SIGMA HP UNI FB KEEL OSTEOTOME WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS 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. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.

Description of Event or Problem

WHEN USING THE TIBIAL OSTEOTOME TO REMOVE THE BONE FROM THE KEEL SLOT, THE METAL BUTTON AT THE END OF THE OSTEOTOME CAME LOOSE BECAUSE OF A HAMMER BLOW. WHEN REMOVING THE OSTEOTOME THE WHOLE INSTRUMENT FELL APART.

Additional Manufacturer Narrative

PRODUCT COMPLAINT (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "WHEN USING THE TIBIAL OSTEOTOME TO REMOVE THE BONE FROM THE KEEL SLOT THE METAL BUTTON AT THE END OF THE OSTEOTOME CAME LOOSE BECAUSE OF A HAMMER BLOW. WHEN REMOVING THE OSTEOTOME THE WHOLE INSTRUMENT FELL APART". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (COMPLAINT (B)(4)). THE PHOTO INVESTIGATION REVEALED THAT SIGMA HP UNI FB KEEL OSTEOTOME HAS BEEN BROKEN . POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY USE OF EXCESSIVE FORCE IN A PRYING MOTION AND OVERLOAD OF THE MATERIAL. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [SIGMA HP UNI FB KEEL OSTEOTOME ] WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, UNINTENDED USE ERROR AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE 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 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.

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: D4 (LOT), D9, H4. CORRECTED: D4 PRIMARY UDI NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.