HP EM TIBIAL JIG SPIKED UPROD

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT THE TIBIAL GUIDE WAS NOT FUNCTIONING PROPERLY.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). THIS PRODUCT WAS REPORTED IN ERROR. DEPUY IS NOT THE MANUFACTURER OR SUPPLIER OF THIS PRODUCT. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE TIBIAL GUIDE WAS NOT FUNCTIONING PROPERLY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE HP EM TIBIAL JIG SPIKED UPROD SHOWS SIGNS OF HEAVY USE AND WORN ACCORDING TO THE TIME OF SERVICE, ADDITIONALLY SIGNS OF DISCOLORATION AND DEFORMING CAN BE OBSERVED ON THE KNOB. 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 WITH THE RETURNED MATING SUBCOMPONENTS REVEALED THAT THE HEAD ASSEMBLY WAS ABLE TO ASSEMBLE AND DISASSEMBLE WITH THE DEVICE AS INTENDED. 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 HP EM TIBIAL JIG SPIKED UPROD WOULD HAVE CONTRIBUTED TO A DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO END OF LIFE, AND 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. 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: H1, H3.