BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM DBALL,S

    MDR report key: 3980002 · Received August 5, 2014

    Report

    Report Number
    1045834-2014-12576
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK113476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THAT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER STATING THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER SENT PHOTOGRAPHIC IMAGES FOR EVALUATION. RELIABILITY ENGINEERING REVIEWED THE PHOTOGRAPHIC IMAGES AND DETERMINED THAT THE BEARINGS ON THE DEVICE WERE DAMAGED, WHICH CAUSED DISTINCTIVE MARKINGS ON THE CUTTER DEVICE. IT WAS DETERMINED THAT THIS CAUSED HEAT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING OVER TIME. 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

    DURING SUBSEQUENT FOLLOW-UP WITH THE REPORTER, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE ALLEGED MALFUNCTION OCCURRED DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE REPORTER STATED THE ¿PROBLEM¿ WAS SOLVED¿ BY WAITING. IT WAS FURTHER REPORTED THAT THE ¿PROCEDURE WAS ENDED AFTER THE ONE SPINAL LEVEL¿. 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

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE BECAME HOT WITHIN 30 AND 40 SECONDS WHEN IN USE WITH A CUTTER DEVICE. ACCORDING TO THE REPORT, ¿THE MARKS OF [THE] BEARINGS WERE VISIBLE AFTER USE¿. THE REPORTER STATED THAT THE ATTACHMENT DEVICE WAS ¿BRAND NEW¿. ACCORDING TO THE REPORTER, THERE WAS NO UNUSUAL HANDLING MADE DURING THE INTERVENTION AND ¿REPROCESSING AS THE HOSPITAL ALREADY USED AND CLEANED¿ THE MOTOR DEVICE SYSTEM FOR MORE THAN THREE MONTHS. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. HOWEVER, IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THE REPORTER INDICATED THAT THE PRODUCT OCCURRENCE WAS NOT RELEVANT TO THE HEALTH OF PATIENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458040 6MM DBALL,S DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS G403084706

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE| MOTOR DEVICE