BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC-SAW-ATTACHM F/EPD+APD

    MDR report key: 5054274 · Received September 3, 2015

    Report

    Report Number
    8030965-2015-11458
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR SERVICE, HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE BALL BEARINGS WERE DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL USE 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

    CORRECTION: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT MFR# 8030965- 2015-11458 IS A DUPLICATE OF MFR# 8030965-2014-10253. REFERENCE 8030965-2014-10253 FOR ALL FURTHER REPORTING REGARDING THIS EVENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WOULD NOT ROTATE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
    585654 RECIPROC-SAW-ATTACHM F/EPD+APD INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 1696079

    Patients

    Seq Age Sex Outcome Treatment
    1