BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI AIR DRILL

    MDR report key: 4091519 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-01343
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE BEARING, CASING, AND LEAVES ARE WORN OUT. THE STARTING LEVER IS LOOSE AND THE TUBE IS LEAKING. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER SENT THE DEVICE IN FOR REPAIR. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Description of Event or Problem · 1

    CUSTOMER SENT THE DEVICE IN FOR REPAIR. TECHNICIAN FOUND THAT THE STARTING LEEVER WAS LOOSE, THE CASING AND LEAVES WORN OUT, THE TUBE WAS LEAKING AND THE CONNECTION RING WAS PARTLY CHIPPED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571661 MINI AIR DRILL HWE SYNTHES GMBH 8140

    Patients

    Seq Age Sex Outcome Treatment
    1