BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

    MDR report key: 6591090 · Received May 25, 2017

    Report

    Report Number
    1719045-2017-10500
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    April 26, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    07611819393967
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER PHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 03.114.001, LOT # 9972971: RELEASE TO WAREHOUSE DATE: 02-MAR-2017, EXPIRATION DATE: NA, SUPPLIER: (B)(4): NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 TO DEVICE HISTORY RECORD: SUPPLIER: FLEXTRONICS AMERICA LLC. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    THIS COMPLAINT IS CONFIRMED. THIS ISSUE HAS BEEN IDENTIFIED AND ESCALATED FROM A PREVIOUS COMPLAINT. APPROPRIATE ACTIONS HAVE BEEN INITIATED/TAKEN TO ADDRESS THE MATTER. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2017 THE DRILL SLEEVE COULD NOT BE INSERTED INTO THE PLATE HOLE. THE DRILL SLEEVE WAS REPLACED WITH ANOTHER DRILL SLEEVE. HOWEVER THE REPLACED DRILL SLEEVE COULD NOT BE INSERTED INTO THE PLATE HOLE EITHER. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371276 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES GUIDE FZX SYNTHES MONUMENT 9972971 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1