BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ACORN-SHAPED L Ø 6.0MM HEAD LENGTH 8.0MM

    MDR report key: 3890863 · Received June 24, 2014

    Report

    Report Number
    9612488-2014-10240
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THIS COMPLAINT, IT WAS DETERMINED THAT THE REPORTED EVENT WAS INCORRECTLY FILED AS A SERIOUS INJURY. BASED ON THE REVIEW, IT WAS DETERMINED THAT THE SERIOUS INJURY WAS CAUSED BY THE COMPETITOR'S DEVICE. SYNTHES DEVICES WERE NOT IN USE AT THE TIME THE SERIOUS INJURY OCCURRED. THEREFORE, THE REPORTED EVENT HAS BEEN UPDATED FROM A SERIOUS INJURY TO A DEVICE MALFUNCTION. 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. 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(S) 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE AN ELECTRONIC PEN CONSOLE WOULD ONLY WORK IN REVERSE AND A BURR ATTACHMENT WOULD NOT SPIN AT ALL. THE SETS WERE BOOKED FOR A HIP REVISION CASE TO BURR OUT CEMENT TO PREVENT A FEMUR FRACTURE DURING CEMENT REMOVAL. DURING THE CASE, THE PEN DRIVER WOULD ONLY WORK IN REVERSE AND NOT FORWARD. THE CONSOLE WOULD LIGHT UP BUT THE PEN DRIVE WOULD NOT MAKE ANY NOISE. IN BOTH REVERSE AND FORWARD THE BURR WOULD NOT SPIN IN THE BURR ATTACHMENT. WHILE TRYING TO REMOVE CEMENT WITH RASPS, THE FEMUR CRACKED SO ANOTHER TREATMENT OPTION WAS USED TO FINISH THE PROCEDURE. THE PROCEDURE WAS DELAYED BY FORTY-FIVE MINUTES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368304 BURR ACORN-SHAPED L Ø 6.0MM HEAD LENGTH 8.0MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES BETTLACH 7737923

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention