BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPAL IMPL-HOLDER W/PISTOL GRIP

    MDR report key: 2992893 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-00475
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 19, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6526847 REVEALED THE IMPLANT HOLDER ASSEMBLY WAS MANUFACTURED BY AVALIGN TECHNOLOGIES, NEMCOMED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE PRODUCT WAS CONFORMING AND MET SPECIFICATIONS AT THE TIME OF RELEASE TO WAREHOUSE. THE INVESTIGATION HAS SHOWN THAT ONE SIDE OF THE HOLDING TIP IS INDEED CRACKED, BENT. UNFORTUNATELY ONLY THE INNER SHAFT HAS BEEN RETURNED. AS YOU INDICATED, THE HAMMER HIT THE TIP DURING THE OPERATION AND CAUSED THE DAMAGE ON ONE SIDE OF THE HOLDER. WE SUPPOSE THAT THE SURGEON DID TRY TO POSITION THE IMPLANT IN SUCH A WAY THAT TOO MUCH FORCE RESULTED IN THE DAMAGE OF THE TIP. THE PRESENT INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2013 WHEN A HAMMER STRUCK THE HEAD OF AN OPAL IMPLANT HOLDER CONSTRUCT THE DEVICE APPEARED TO BECOME DEFORMED AND SLIT. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98092 OPAL IMPL-HOLDER W/PISTOL GRIP LXH SYNTHES MONUMENT 6526847

    Patients

    Seq Age Sex Outcome Treatment
    1