BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 7477639 · Received May 1, 2018

    Report

    Report Number
    8030965-2018-53482
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    0761181950170
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. FACILITY ADDRESS AND REPORTER PHONE NUMBER NOT PROVIDED FOR REPORTING. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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

    PART 03.010.404, LOT U210481: RELEASE TO WAREHOUSE DATE: OCTOBER 22, 2014. SUPPLIER: ORCHID UNIQUE. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED CONNECTING SCREW, CANNULATED AND THE INSERTION HANDLE WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS AND FOR FUNCTIONING. THE REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT BOTH PARTS WERE MANUFACTURED IN OCTOBER 2014 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. NOT ALL THE PARTS OF THE COMPLAINT WERE RETURNED FOR AN EVALUATION. WITHOUT THE SCREWDRIVER AND THE NAIL, THE COMPLAINT SITUATION COULD NOT BE REPRODUCED. USING OTHER EXEMPLARY ARTICLES FOR A FUNCTION TEST, THE COMPLAINT ISSUE COULDN¿T BE REPRODUCED. EVEN THOUGH THE RETURNED PARTS SHOW WEAR AND SIGN OF USE, THE CONNECTION OF THE ARTICLES IN SCOPE COULD BE DONE WITHOUT HAVING THEM GET STUCK. THE COUPLING WORKS AS INTENDED. THE INVESTIGATION FOUND NO PRODUCT RELATED ISSUES THAT WOULD HAVE CONTRIBUTED 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 DURING A SURGERY ON (B)(6) 2018, AFTER IMPLANTING THE NAIL AND BACKSTROKING IT FOR COMPRESSION, SURGEON WAS NOT ABLE TO REMOVE THE NAIL FROM THE INSERTION HANDLE. TOO MUCH STRESS WAS ON THE CONNECTION, THE SURGEON EVEN BROKE THE SCREWDRIVER. THE SURGERY WAS PROLONGED FOR ABOUT 30 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. ALL THE BROKEN OFF FRAGMENTS COULD NOT BE REMOVED FROM THE PATIENT. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW FOR PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318697 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH U210481 0761181950170

    Patients

    Seq Age Sex Outcome Treatment
    1