BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

    MDR report key: 3217642 · Received July 10, 2013

    Report

    Report Number
    8030965-2013-04184
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: POWER TOOL EVALUATION WAS COMPLETED AND THE COMPLAINT OF THE SMALL BATTERY DRIVE(001613) HAS NO POWER WAS CONFIRMED. THE UNIT WAS TESTED AND COMPLAINT WAS SUBSTANTIATED. THIS IS MOST LIKELY DUE INTERNAL MOTOR OR ECU FAILURE DUE TO USAGE OVER TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT RECEIPT DATE UPDATED TO 10/14/2013.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING AN ORAL EXTRACTION PROCEDURE ON (B)(6) 2013, THE BURR ATTACHMENT WOULD NOT SPIN. REPORTEDLY A SPARE ATTACHMENT WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO DELAY TO THE PROCEDURE AND NO HARM TO PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318410 DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS HWE SYNTHES GMBH 1613

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR