BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OILING ADAPTER F/2 HOSE MACHINE

    MDR report key: 3820070 · Received May 20, 2014

    Report

    Report Number
    3009450871-2014-10138
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE BY THE COMPLAINT HANDLING UNIT REVEALED NO SIGNS OF DAMAGE WAS VISIBLE. 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. BASED ON THE INVESTIGATION RESULTS FROM THE (B)(4) AND A FUNCTIONAL TESTS WITH AIR HOSE COUPLINGS - IT'S RUNNING SMOOTH. THE ADAPTER IS IN WORKING ORDER. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO 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. 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 THE DEVICE WAS CONNECTED TO A COMPACT AIR DRIVE SUDDENLY BROKE WITH AN EXPLOSION SOUND DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR THE SURGEON. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300332 OILING ADAPTER F/2 HOSE MACHINE MISC ORTHO SURGICAL INSTR HWE DEPUY SYNTHES POWER TOOLS MS1201

    Patients

    Seq Age Sex Outcome Treatment
    1