BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 4210449 · Received October 29, 2014

    Report

    Report Number
    3003875359-2014-10347
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED ARTICLE WAS INVESTIGATED. THE INSERTER SHOWS EXCESSIVE HAMMERING MARKS BOTH ON THE SURFACE AND THE UNDERSIDE OF THE METAL SECTION. THE TECHNIQUE GUIDE (B)(4) MUST REFERENCED FOR CORRECT USE OF THIS ARTICLE. THERE IS A ¿SQUEAKING¿ NOISE WHEN THE CHUCK IS ROTATED. THIS IS FROM INSUFFICIENT / NO LUBRICATION OF THE ARTICLE WITH OIL AS RECOMMENDED IN THE INSTRUCTIONS THAT WOULD HAVE BEEN RECEIVED WHEN THIS ARTICLE WAS PURCHASED. THIS MAINTENANCE IS A REQUIREMENT TO KEEP THIS INSTRUMENT IN OPTIMUM CONDITION. WE CONDUCTED A FULL DHR REVIEW FOR THIS ARTICLE AND IT WAS MANUFACTURED TO THE HIGHEST SPECIFICATIONS AND INSPECTED BEFORE RELEASE IN JUNE 2013. NO PRODUCT FAULT COULD BE FOUND. 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. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PHYSICIAN RETURNED A BROKEN DEVICE. IT WAS REPORTED THE DEVICE BROKE DURING A PROCEDURE ON (B)(6), 2014. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691691 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8404433

    Patients

    Seq Age Sex Outcome Treatment
    1