BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC

    MDR report key: 10053355 · Received May 13, 2020

    Report

    Report Number
    8030965-2020-03503
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    February 1, 2020
    Report Date
    April 30, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819753419
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (BROKEN TIP) BASED ON THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED THEREFORE NO FURTHER INVESTIGATION POSSIBLE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY PART NUMBER:313.932, SYNTHES LOT NUMBER: U250429, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 12OCT 2016, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO 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. 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

    EVENT DATE IS UNKNOWN WITH 2020. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLOSED CRANIAL SURGERY, THE HEAD OF DRIVERS WERE BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515734 LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC SCREWDRIVER HXX OBERDORF SYNTHES PRODUKTIONS GMBH U250429 07611819753419

    Patients

    Seq Age Sex Outcome Treatment
    1 SCRDRIVER SHAFT PLUSDRIVE 1.6 L66