BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT 3.5 T15 L250 F/AO/ASIF

    MDR report key: 3168383 · Received June 13, 2013

    Report

    Report Number
    1719045-2013-01616
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 16, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORD FOR LOT # 6182072 REVEALED THE T-15 SCREWDRIVER SHAFT WAS MANUFACTURED BY UNIVERSAL PUNCH, FOR 104 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 031FI00045 REV E ON 9/9/09. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 9/1/09. 104 PARTS WERE RELEASED TO THE WAREHOUSE ON 9/10/09. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION OF THE COMPLAINED SCREWDRIVER SHOWS THAT THE TIP IS BROKEN OFF. THE FRACTURE SURFACE OF THE BROKEN AREA SHOWS THAT THE MATERIAL GOT TWISTED AND BROKE AWAY DUE TO TOO MUCH FORCE THAT WAS APPLIED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND, THE ARTICLE CONFORMS TO OUR SPECIFICATIONS. THE ARTICLE WAS MANUFACTURED ON DECEMBER THE 29TH 2010 ACCORDING TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH A PELVIC FRACTURE. DURING THE PROCEDURE ON (B)(6) 2013 USING THE LOW PROFILE PELVIC SYSTEM, THE SURGEON WAS FIXING THE SS LOCKING SCREW, IT WAS REPORTED THE HEAD OF THE SCREWDRIVER BROKE. THE SURGEON REMOVED IT AND TRIED TO FIX IT USING A COMPETITORS T15 SCREWDRIVER THAT ALSO BROKE. REPORTEDLY THE COMPETITORS SCREWDRIVER HEAD WAS BITING IN THE TORX HEAD OF THE SCREW AND WAS NOT REMOVED. IT WAS REPORTED THE TORQUE LIMITING ATTACHMENT WAS NOT USED DURING THE INSERTION OF THE SS LOCKING SCREW. THE SURGEON OVER-ROTATED BECAUSE HE BELIEVED TO FIX IT BY A CLICK SOUND. THERE IS NO PLAN TO EXPLANT THE IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268820 SCRDRIVER SHAFT 3.5 T15 L250 F/AO/ASIF HXX SYNTHES MONUMENT 6182072

    Patients

    Seq Age Sex Outcome Treatment
    1 COMPETITORS T15 SCREWDRIVER