BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 15384887 · Received September 8, 2022

    Report

    Report Number
    1818910-2022-17474
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    June 6, 2022
    Report Date
    September 8, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295216599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED. AFTER PHYSICAL REVIEW, IT WAS IDENTIFIED THAT THE ETCHING NUMBERS WERE CLEARLY VISIBLE AND LEGIBLE. HOWEVER, IT WAS IDENTIFIED SIGNIFICANT WEAR ON BOTH JAWS. NO OTHER ISSUES WERE OBSERVED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. BASED ON THE INITIAL REPORT THE SURGEON INDICATES THAT WHEN USING THE PATELLA GAUGE TO MAKE THE CUT (CODE: 865034 CALIBRATED CUTTING GUIDE FOR PATELLA), THE NUMBERS WERE NOT VISIBLE ON THE INSTRUMENTS AND IT COULD NOT ESTABLISH THE CORRESPONDING THICKNESS TO MAKE THE CUT. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT ETCHING NUMBERS OF THE PFC*CALIBRATED PAT CUT GDE (P/N: 865034, LOT: SO2022803) WERE CLEARLY VISIBLE AND LEGIBLE. HOWEVER, IT WAS IDENTIFIED SIGNIFICANT WEAR ON BOTH JAWS, WHICH COULD BE ATTRIBUTED TO REPETITIVE USE AND END OF LIFE INDICATOR. NO OTHER ISSUES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE PFC*CALIBRATED PAT CUT GDE SINCE IT WAS NOT APPLICABLE FOR THIS COMPLAINT. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE FC*CALIBRATED PAT CUT GDE (P/N: 865034, LOT: SO2022803) WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. HOWEVER, IT WAS IDENTIFIED SIGNIFICANT WEAR ON BOTH JAWS CONSISTENT WITH END OF LIFE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED? -DWG-11762C27 KNEE SYS. CALIBRATED PATELLAR CUTTIUNG GUIDE ASSEMBLY, CURRENT REV. J DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE FOR THIS COMPLAINT. 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. 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 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 · 0

    THE SURGEON INDICATES THAT WHEN USING THE PATELLA GAUGE TO MAKE THE CUT (CODE: 865034 CALIBRATED CUTTING GUIDE FOR PATELLA), THE NUMBERS WERE NOT VISIBLE ON THE INSTRUMENTS AND IT COULD NOT ESTABLISH THE CORRESPONDING THICKNESS TO MAKE THE CUT. THE SAME PROBLEM HAPPENED WHEN THEY WANTED TO MEASURE THE CUT OF THE DISTAL FEMUR WITH THE INSTRUMENT CODE: 96112, WHICH IS THE GAUGE FOR THE FEMUR CUT GUIDE. WHEN THEY WANTED TO MAKE THE HOLES TO ANCHOR THE PATELLA IN THE BONE, THE CORRESPONDING DRILL BIT WAS NOT VERY SHARP AND THEY HAD TO PRESS HARDER (CODE: 868800) PFC SIGMA OVAL PATELLA DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284293 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS HWT DEPUY ORTHOPAEDICS INC US 86-5034 SO2022803 10603295216599

    Patients

    Seq Age Sex Outcome Treatment
    1 Female