BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD BENDER FOR 6.0MM RODS W/RADIUS ADJUSTMENT & SPRING

    MDR report key: 3660205 · Received March 5, 2014

    Report

    Report Number
    1719045-2014-10019
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWNIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ROD BENDER FOR 6.0MM RODS W/RADIUS ADJUSTMENT & SPRING A MANUFACTURING EVALUATION WAS COMPLETED: DUE TO AN UNKNOWN CAUSE, ONE OF THE LEAF SPRINGS AND THE SCREW WHICH HOLDS IT IN PLACE IS MISSING. THE INSTRUMENT EXHIBITS SIGNS OF NORMAL USE. (B)(4) MANUFACTURED THE ROD BENDER FOR 6.0MM RODS WITH RADIUS ADJUSTMENT AND SPRING. THE LOT INITIALLY CONFORMED TO SPECIFICATIONS AS NOTED IN THE CERTIFICATE OF COMPLIANCE AND THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE COMPLAINT CONDITION OF THE ROD BENDER HAS AN ISSUE WITH THE SPRING PORTION BECOMING LOOSE IS CONFIRMED, HOWEVER, BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THE FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES AT (B)(4). INCORRECT DATE ENTERED ON FOLLOW UP MEDWATCH, DATE ENTERED ON INITIAL MEDWATCH OF MARCH 17, 2006 IS CORRECT. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDES HXW. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. 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 THE TIP IS WORN AND PARTIALLY BROKEN OFF THE STARDRIVE SHAFT, THE ROD BENDER HAS AN ISSUE WITH THE SPRING PORTION BECOMING LOOSE, THE MATRIX SIMPLE PERSUADER IS STICKY AND DIFFICULT TO RELEASE, THE LOCKING HOLDING SLEEVE'S TIP IS DEFORMED WHERE THE DEVICE THREADS INTO THE SCREW AND THE RATCHET HANDLE DOES NOT GRIP EASILY. THE EVENTS ARE NOT PART OF ANY SPECIFIC CASE AND THERE IS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR ROD BENDER (03.620.020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131637 ROD BENDER FOR 6.0MM RODS W/RADIUS ADJUSTMENT & SPRING PLIERS,SURGICAL HTC SYNTHES MONUMENT 562376C06

    Patients

    Seq Age Sex Outcome Treatment
    1