BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 3838785 · Received May 29, 2014

    Report

    Report Number
    9680938-2014-10028
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE JAWS WERE CHIPPED. THE REPAIR TECHNICIAN REPORTED THE JAWS WERE CRACKED AND DAMAGED. CUTTING JAWS BROKEN IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: JAW/BOLT SYSTEM. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON (B)(4) 2014. THE EVALUATION WAS CONFIRMED. 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

    ADDITIONAL NARRATIVE: 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING A CASE WHILE THE SURGEON WAS CUTTING A ROD, THE JAWS CHIPPED ON BOTH DEVICES. THERE WAS NO INJURY TO THE PATIENT, ALL FRAGMENTS WERE CONFIRMED BY X-RAY TO HAVE BEEN RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADDITIONAL INTERVENTION OR EXTENDED TIME TO THE PROCEDURE AS THE FRAGMENTS WERE REPORTED TO BE EASILY REMOVED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316982 ROD CUTTER CUTTER, WIRE HXZ SYNTHES TUTTLINGEN T991783

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR