BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3944556 · Received July 18, 2014

    Report

    Report Number
    1719045-2014-10321
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SERVICE HISTORY REVIEW: LOT 5880024 A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.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

    THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE PART WAS RETURNED TO THE SUPPLIER ALREADY DISASSEMBLED. THE SUPPLIER STATED, ¿THE SWITCH WAS RE-ATTACHED TO THE CIRCUIT BOARD. THE MOTOR RAN CONTINUOUSLY, WHEN ATTACHED TO A BATTERY, WITHOUT ANY BUTTONS ON THE SWITCH BEING ACTUATED. THE SWITCH WAS REMOVED AND WAS REPLACED WITH A NEW SWITCH. THE MOTOR FUNCTIONED AS EXPECTED¿THE CONTACT PLATE WAS FOUND TO HAVE DAMAGE ON ONE OF THE CORNERS DURING VISUAL INSPECTION¿THERE WAS A SMALL PIECE MISSING FROM AROUND ON COUNTERSINK AND SOME DAMAGE ON THE CORNER WHERE THE MATERIAL WAS MISSING. THERE WAS SOME DAMAGE FOUND ON THE BOTTOM (OF THE SWITCH) DIRECTLY UNDER THE FAST FORWARD BUTTON. IT WAS ALSO FOUND THAT THE METAL CONTACT PLATES UNDER THE FORWARD AND REVERSE BUTTONS WERE BENT OUTWARD AND LOCKED IN THE ACTUATED POSITION.¿ THE SUPPLIER CONCLUDED, ¿IT IS THE OPINION OF THE AUTHOR THAT THE SWITCH WAS THE CAUSE OF THE COMPLAINT. THE SWITCH¿S CONTACT PLATE BECAME BENT DUE TO EXCESSIVE ACTUATION FORCE AND/OR EXTENSIVE FIELD USE WHICH CAUSE THE DEVICE TO BE LOCKED IN THE ACTUATED POSITION AND BREAK AS THE COMPLAINT STATED.¿ BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONFIRMED BUT IS NOT CONSIDERED MANUFACTURING-RELATED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: GXL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE UNIT WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE MOTOR SOUNDED BAD, WAS RUNNING SLOW, AND THE BASE PLATE WAS CRACKED. MOTOR FAILURE IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: BASE PLATE, CIRCUIT BOARD, MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER.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

    IT WAS REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER IS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423212 HAND PIECE FOR BATTERY POWERED DRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 5880024

    Patients

    Seq Age Sex Outcome Treatment
    1