BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 3831642 · Received May 26, 2014

    Report

    Report Number
    3009450871-2014-10165
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE OPTICAL CHECK WAS ACCEPTABLE. INITIALLY, THE DEVICE WAS INSPECTED FOR OPTICAL DAMAGES. RESULT: NO OPTICAL DAMAGES VISIBLE. THE DEVICE WAS TESTED AND PROVEN AND NO INSUFFICIENCIES COULD BE IDENTIFIED. THE DESCRIBED EXPLOSION NOISE WITHIN THE COMPLAINT DESCRIPTION BELONGS TO THE EXPLODED AIR HOSE. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPACT AIR DRIVE WAS REPORTED TO HAVE BEEN IN USE WITH AN AIR HOSE AND ADAPTER WHICH SUDDENLY BROKE WITH AN EXPLOSION SOUND DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE SURGEON. DURING SURGERY, 10-MINUTE SURGICAL DELAY, NO PATIENT HARM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309955 COMPACT AIR DRIVE II INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1