BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDEWITH DEPTH GAUGE

    MDR report key: 4770052 · Received May 13, 2015

    Report

    Report Number
    3003875359-2015-10208
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INITIALS: (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED AND THE: MANUFACTURING SITE (B)(4), MANUFACTURING DATE: 02. MAY. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: TWO OF THE FOLLOWING DEVICE(S) WAS RECEIVED: 1.5MM THREADED DRILL GUIDE (PART 323.034 / LOT 8901583 / MANUFACTURE DATE: MAY 2014). THE RETURNED DEVICES ARE IN EXCELLENT CONDITION. THERE IS NO DAMAGE PRESENT ON THE DEVICES AND THE THREADS APPEAR UNDAMAGED. A 2.0MM LCP CONDYLAR PATE (PART NUMBER 247.349, LOT NUMBER 3447748) WAS MATED WITH THE RETURNED DRILL GUIDES. AT NO TIME DID THE DRILL GUIDES FAIL TO PROPERLY CONNECT TO THE PLATE. THUS, THE COMPLAINT CONDITION IS UNCONFIRMED AND COULD NOT BE REPLICATED. THE DEVICE HISTORY RECORD SHOWED THAT NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION, AND THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS UNCONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE IMPLANTING A 6 HOLE 2 MM TITANIUM LOCKING COMPRESSION PLATE (LCP), TWO 2.0 LOCKING TOWERS WOULD NOT SCREW INTO THE PLATE PROPERLY. TIME DELAY FIVE (5) MINUTES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE IMPLANTING A 6 HOLE 2 MM LOCKING COMPRESSION PLATE (LCP), TWO 1.5 MM THREADED DRILL GUIDES WOULD NOT SCREW INTO THE PLATE PROPERLY. THE REPORTED ISSUE RESULTED IN A FIVE MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313665 1.5MM THREADED DRILL GUIDEWITH DEPTH GAUGE GUIDE FZX SYNTHES HAGENDORF 8901583

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR