BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW BLADE ZIMMER UNIVERSAL POWER SYSTEMS

    MDR report key: 7004423 · Received November 6, 2017

    Report

    Report Number
    0002950261-2017-00019
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 19, 2017
    Report Date
    February 7, 2018
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(4), LOT NUMBER 38363, IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. PRODUCT EXAMINATION COULD NOT BE PERFORMED AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. A REVIEW USING THE P/N OF THIS COMPLAINT AND ALSO BASED UPON OPEN AND CLOSED COMPLAINTS AND THE KEYWORD SEARCH USING THE CHARACTER STRING ¿BROKE¿ RESULTED IN 1 COMPLAINT. A REVIEW USING THE CRITERIA OF P/N AND COMPLAINT CATEGORY OF THIS COMPLAINT AND ALSO BASED UPON OPEN AND CLOSED COMPLAINTS AND THE KEYWORD SEARCH USING THE CHARACTER STRING ¿BROKE¿ AND SORTED BY MANUFACTURER DATE WAS PERFORMED. THIS REVIEW RESULTED IN THE HIGHEST OCCURRENCE FOR A GIVEN MANUFACTURE DATE WAS 1. REVIEWING THE COMPLAINTS FOR THE LOT NUMBER 38363 SHOWS 1 COMPLAINT FOR THIS PART AND LOT NUMBER. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION AS NO PRODUCT WAS RETURNED FOR THIS COMPLAINT. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHEN TIBIA FINISHING WITH KEEL RECIPROCATING SAW, THE KEEL BROKEN DOWN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782587 RECIPROCATING SAW BLADE ZIMMER UNIVERSAL POWER SYSTEMS BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 38363

    Patients

    Seq Age Sex Outcome Treatment
    1