BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQUE LIMITING ATTACHMENT 1.2NM

    MDR report key: 5359638 · Received January 12, 2016

    Report

    Report Number
    2520274-2016-10131
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 18, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    A MANUFACTURING INVESTIGATION WAS PERFORMED ¿ THE RETURNED TORQUE LIMITING ATTACHMENT WAS SENT FOR A MANUFACTURING EVALUATION WHERE IT WAS TESTED AND FOUND TO BE WITHIN SPECIFICATION. AS THE DEVICE WAS FOUND TO FUNCTION AS INTENDED THE COMPLAINT IS UNCONFIRMED. AN OPTICAL CHECK WAS PERFORMED AND THE DEVICE LOOKED OK. ALL TESTING WAS PERFORMED ACCORDING TO THE SERVICE MANUAL AND ALL REQUIREMENTS PASSED. ADDITIONALLY THE RETURNED TORQUE LIMITER HAD TORQUE VALUES RECORDED AND ALL RECORDED VALUES WERE WITHIN SPECIFICATION. EVIDENCE IS SUGGESTIVE OF WRONG HANDLING. DHR REVIEW - LOT# 1000932. RELEASE TO WAREHOUSE DATE: 01APR2014. SUPPLIER: SYNTHES-(B)(4), PACKAGED BY: SYNTHES: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT ONE (1) 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW 12MM AND TWO (2) 2.7MM VA LOCKING SCREWS 14MM STRIPPED AS THEY WERE BEING INSERTED INTO A PLATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE FIBULA ON (B)(6) 2015. THE SCREWS WERE SUCCESSFULLY REMOVED WITH NO RETAINED FRAGMENTS. ALTERNATE SCREWS WERE IMMEDIATELY AVAILABLE FOR USE, BUT THE PROCEDURE WAS PROLONGED BY THIRTY (30) MINUTES. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20262 TORQUE LIMITING ATTACHMENT 1.2NM MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 1000932

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention