SP2 PAT PLANER BODY MED

Additional Manufacturer Narrative

THE DEVICE MALFUNCTION, DEVICE INTERACTION (2+ DEVICES) : JAMMED/SEIZED, WILL NO LONGER BE REPORTED AS THERE HAS NOT BEEN A SERIOUS INJURY ASSOCIATED WITH THIS FAILURE WITHIN THE PAST 2 YEARS. PLEASE CONSIDER THIS THE LAST MANUFACTURER REPORT NUMBER SUBMITTED AGAINST THIS MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT THE BLADE GOT STUCK ON THE MEDIUM PATELLA REAMER AND DID NOT COME OFF. THE RED KNOB ON THE SIDE OF THE ATTUNE FEMORAL INTRODUCER FELL OFF WHEN IMPACTING.

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. H4: MANUFACTURE DATE IS AN UNKNOWN DAY IN (B)(6) 2006. H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE SP2 PAT PLANER BLDE/CTR DRL MD IS REMAIN ATTACHED TO THE SP2 PAT PLANER BODY MED, HOWEVER THE ASSEMBLY AREA OF THE PLANER BODY LOOKS DEFORMED AND WORN CONSISTENT WITH THE TIME OF SERVICE OF THE DEVICE. 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 FUNCTIONAL TEST WAS PERFORMED AND AFTER MULTIPLE ATTEMPTS REVEALED THAT THE BLADE WAS UNABLE TO MOVE DUE TO THE OBSERVED CONDITION ON THE PLANAR BODY, CONFIRMING THE JAMMED AND UNABLE TO DISASSEMBLE ALLEGATIONS. 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 SP2 PAT PLANER BODY MED 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 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. A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE DATE CODE H0306 PROVIDED IS NOT A VALID FINISHED GOODS LOT NUMBER.

Additional Manufacturer Narrative

THE DEVICE MALFUNCTION, DEVICE INTERACTION (2+ DEVICES) : UNABLE TO DISASSEMBLE , WILL NO LONGER BE REPORTED AS THERE HAS NOT BEEN A SERIOUS INJURY ASSOCIATED WITH THIS FAILURE WITHIN THE PAST 2 YEARS. PLEASE CONSIDER THIS THE LAST MANUFACTURER REPORT NUMBER SUBMITTED AGAINST THIS MALFUNCTION.