BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 4183197 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14138
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 17, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, THE DEVICE WAS FOUND TO BE NOT FUNCTIONING PROPERLY AND EXHIBITED ABOVE-SPECIFICATION TEMPERATURES; THE CAUSE IS NORMAL WEAR. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION NOT PREVIOUSLY REPORTED. DATE RECEIVED BY MANUFACTURER: 15-DEC-2014; DATE OBSERVED. 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

    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.

    Description of Event or Problem · 1

    UPDATE: 12/5/2014 - ADDITIONAL INFORMATION FOR CLARIFICATION: PRODUCT OCCURRENCE NOT RELEVANT TO THE HEALTH OF THE PATIENT OR USER. DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN INDICATED THE TEMPERATURE WAS OVER THE SPECIFIED AMOUNT AND THE BEARINGS AND GEARS WERE DEFECTIVE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR AN UNSPECIFIED REASON. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661017 8CM ANGLE ATTACHMENT, BLACK MAX DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1