BLADE L120

Additional Manufacturer Narrative

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. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY ACCORDING TO INFORMATION RECEIVED, DURING THE LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED: BEISPIEL: ITEM CANT HOLD THE LETTER (SEE PHOTOS ATTACHED) IMPORTANT: THE PRODUCT WAS NOT COMPLAINED BY ANY CUSTOMER. THERE IS NO PATIENT IMPACT, NO SURGERY DELAY AND NO CUSTOMER IMPACT! THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND THE DEVICE WAS WORN OUT BY REPEATED USAGE; SCRATCHES ALL OVER THE SURFACE WERE OBSERVED, INCLUDING THE ATTACHING MECHANISM. 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 MATING DEVICE, AND EVEN THOUGH ASSEMBLING WAS POSSIBLE, DUE TO THE CONDITION OF THE DEVICE, THE ASSEMBLING WAS LOOSE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE BLADE L120 WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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. THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: DWG SE_407168 REV L (CURRENT) / REV. H (MANUFACTURED) DIMENSIONAL INSPECTION: N/A DEVICE HISTORY LOT PRODUCT CODE: : 03.816.120 LOT NUMBER : 8310924 RELEASE TO WAREHOUSE DATE : 21.MAR.2013 MANUFACTURING SITE: WERK HÄGENDORF. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 DURING LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT ON (B)(6) 2024, IT WAS IDENTIFIED THAT THE BLADE HOLDER COULD NOT HOLD THE LETTER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A BLADE HOLDER-RIGHT.