BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS

    MDR report key: 15631299 · Received October 19, 2022

    Report

    Report Number
    8030965-2022-08405
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819847217
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INITIAL REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    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. H3, H4, H6: PART: 03.108.001; LOT: 9718863; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 26 JANUARY 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 THE AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL HAD A SMALL FRAGMENT OF AN UNRECOGNIZED K-WIRE STUCK AT THE RIGHT INSERTION HOLE. THE DEVICE PRESENTS NICKS ALONG THE EDGES OF THE DISTAL END OF THE BLOCK. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL AND MET SPECIFICATIONS. A FUNCTIONAL TEST WAS PERFORMED, THE FRAGMENT OF THE K-WIRE WAS UNABLE TO BE RETRIEVED FROM THE INSERTION HOLE OF THE GUIDING BLOCK. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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? YES, REVIEWED. DIMENSIONAL INSPECTION: CONFORMING. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT THE LG PED LCP HIP PL GUIDING BLOCK FAILED. THIS PARALLEL GUIDE HAD TROUBLE PASSING THE K NEEDLE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) LG PED LCP HIP PL GUIDING BLOCK 3.5 SCRS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    THE PATIENT STATUS IS GOOD AND WITHOUT PROBLEMS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR ONE PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045830 PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH SD03.108.001 9718863 07611819847217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - GUIDE/COMPRESSION/K-WIRES