BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-SITU BENDING & TWISTING HANDLE/120°

    MDR report key: 3800728 · Received May 8, 2014

    Report

    Report Number
    9680938-2014-10016
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THE VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE INVESTIGATION OF THE COMPLAINED INSTRUMENT SHOWS THAT A PART OF THE TIP IS BROKEN AT THE WELDING. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. NO PRODUCT FAULT COULD BE DETECTED. 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PART OF THE INSTRUMENT WAS BROKEN WHILE BENDING A 3.5 RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279182 IN-SITU BENDING & TWISTING HANDLE/120° INSTR, BENDING OR CONTOURING HXP SYNTHES TUTTLINGEN T968408

    Patients

    Seq Age Sex Outcome Treatment
    1