BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 7673155 · Received July 10, 2018

    Report

    Report Number
    8030965-2018-54893
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Report Date
    June 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819096653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 359.219; LOT: 8073091; MANUFACTURING LOCATION: HÄGENDORF; RELEASE TO WAREHOUSE DATE: OCTOBER 04, 2012; NO NONCONFORMANCE REPORTS (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. INVESTIGATION SITE: CQ ZUCHWIL; SELECTED FLOW: 5. BROKEN . VISUAL INSPECTION: THE VISUAL INSPECTION HAS SHOWN THAT THE CROSS-BAR LONG IS BROKEN OFF AND HAS SEVERAL STRONG IMPACTS AND HAMMERING MARKS AT THE ENTIRE PART. BESIDES, THE THREE JAWS ARE ALL DEFORMED. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED. THIS MANUFACTURING LOT 8073091 WAS MANUFACTURED IN OCTOBER 2012 ACCORDING TO THE SPECIFICATION. THIS PARTICULAR DEVICE, BEARING THE LOT NUMBER 8073091, HAS BEEN AFFECTED BY A RECALL R2014189 / DELIVERY STOP. WE INITIATED IMMEDIATE STEPS TO PREVENT REOCCURRENCE OF THIS FAILURE. 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

    NO PATIENT INVOLVEMENT HAS BEEN REPORTED. IT IS UNKNOWN WHEN DEVICE BROKE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ON (B)(6) 2018, A CUSTOMER SENT A REQUEST FOR A REFUND FOR AN INSERTER TO TITANIUM (TI) ELASTIC NAILS. THIS INSTRUMENT HAD BEEN AFFECTED BY A RECALL FROM 2015. THERE IS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THE DEVICE WAS RECEIVED ON (B)(6) 2018 AND WAS DISCOVERED TO BE BROKEN. THIS REPORT IS FOR A INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514863 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 8073091 07611819096653

    Patients

    Seq Age Sex Outcome Treatment
    1