BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE

    MDR report key: 12314550 · Received August 12, 2021

    Report

    Report Number
    8030965-2021-06612
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819431263
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H6: PART # 04.019.000S, LOT # 102P562, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 27 APR 2021, EXPIRY DATE: 01 APR 2031. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI THE THREADS OF THE SCREW WERE DEFORMED, AND NO OTHER DEFECTS WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE FUNCTIONAL TEST WAS NOT PERFORMED SINCE THE DEVICE WAS RECEIVED BY ITSELF BUT THE ALLEGED UNABLE TO ASSEMBLE CONDITION CAN BE CONFIRMED SINCE THE THREADS WERE DEFORMED MIGHT BE THE REASON FOR THE ALLEGED COMPLIANT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI. 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? END CAP F/ MULTI LOC HN/PHN. 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. 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 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 · 1

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR OPEN REDUCTION INTERNAL FIXATION SURGERY OF THE PROXIMAL HUMERAL SHAFT FRACTURE. DURING THE ENDCAP INSERTION, THE ENDCAP COULDN'T BE INSERTED PROPERLY. THE SURGEON TRIED TO EXTEND OR INVERT THE PATIENT, BUT IT COULDN'T BE INSERTED. FINALLY, THE SURGERY WAS COMPLETED WITHIN 30MINUTES DELAY WITHOUT ENDCAP INSERTED. THERE IS NO PLAN TO REMOVE NAIL. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO(2) DEVICES. THIS REPORT IS FOR (1) TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211105 TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH 102P562 07611819431263

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR MULTILOC HN Ø7 R CANN L225 TAN| UNK - SCREWS: LOCKING| MULTILOC HN Ø7 R CANN L225 TAN| UNK - SCREWS: LOCKING