BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE Ø1 L150 SST 10U

    MDR report key: 3875285 · Received June 16, 2014

    Report

    Report Number
    3009450863-2014-10013
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    LRN
    PMA / PMN Number
    PPRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION AND A MANUFACTURING EVALUATION WERE COMPLETED: THE 19 K-WIRES WERE RETURNED IN A DAMAGED STATE WITH VARYING AMOUNTS OF SCRATCHES. (B)(4) PARTS SHOWED NO DAMAGE AT ALL. (B)(4) PARTS SHOWED MINIMAL DAMAGE, WHICH MAY BE THE RESULT OF A NORMAL USE. (B)(4) PARTS WERE HEAVILY DAMAGED. THE COLIBRI DEVICE MENTIONED IN THE COMPLAINT WAS NOT PROVIDED. THE HEAVILY DAMAGED K-WIRES SUGGEST THAT THESE PARTS WERE MISUSED. WRONG POWER TOOL CLAMPING SETTING, NOT ENOUGH MANUAL PRESSURE OR MULTIPLE USE OF THESE SINGLE-USE ITEMS ARE MOST LIKELY. IT IS MENTIONED IN THE COMPLAINT THAT K-WIRES AND TOOLS OF MULTIPLE COMPANIES ARE BEING USED AT THIS SITE. WITHOUT KNOWLEDGE OF WHICH INSTRUMENT WAS USED WITH WHICH K-WIRE A CLOSER INVESTIGATION IS NOT POSSIBLE. FURTHER INVESTIGATION REGARDING THE MANUFACTURING AND RAW MATERIAL DOCUMENTS SHOWS CONFORMITY TO THE SPECIFICATION AS WELL. 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 NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. COMMENT WAS INCORRECTLY ADDED ON INITIAL REPORT THAT THIS WAS AN INSTRUMENT, THE KIRSCHNER WIRE IS AN IMPLANT. 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 THERE WAS A PROBLEM WITH THE QUICK COUPLING GETTING METAL PARTICLES AFTER CLEANING. THE PRODUCT WAS USED WITH BOTH SYNTHES AND NON-SYNTHES K-WIRES. THE NON-SYNTHES COMPANIES ARE ALSO BEING CONTACTED ABOUT THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352568 K-WIRE Ø1 L150 SST 10U WIRE,SURGICAL LRN SYNTHES BALSTHAL 8804797

    Patients

    Seq Age Sex Outcome Treatment
    1