BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 5934134 · Received September 7, 2016

    Report

    Report Number
    3003875359-2016-10477
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    August 19, 2016
    Report Date
    August 19, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 27, 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED DRILL GUIDES (323.034, 8980903) ARE THREADED INTO PLATES DURING FIXATION AND USED TO GUIDE A DRILL BIT THROUGH A PLATE, AND CAN ALSO BE USED TO DETERMINE APPROPRIATE SCREW LENGTH REQUIRED FOR PROPER IMPLANTATION. THE RETURNED DRILL GUIDES ARE ONLY DESIGNED TO BE USED WITH THE 2.0MM PLATES. THE DEVICES WERE IDENTIFIED IN LITERATURE FOR THE MODULAR MINI FRAGMENT SET, THE 2.0MM LCP DISTAL ULNA PLATE, AND THE ROTATION CORRECTION PLATES- 2.0MM LCP AND 1.2MM/2.0MM. THE INVESTIGATION WAS COMPLETED BASED ON PICTURES OF THE RETURNED DEVICES WHICH WERE INCONCLUSIVE REGARDING DAMAGED THREADED TIPS. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION THROUGH PICTURES, DRAWING REVIEW, ROOT CAUSE ANALYSIS, AND RISK MANAGEMENT ASSESSMENT WERE PERFORMED. THE RETURNED DRILL GUIDES (323.034, 8980903, QUANTITY 2) WERE MANUFACTURED ON JUNE 27, 2014 AND THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR ACTIONS RELATED TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION OF THE RETURNED PART(S). REVIEW OF DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT(S) WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION. UPON REVIEW OF THE ASSOCIATED DRAWINGS AND THE PICTURES OF THE RETURNED PARTS IT WAS REALIZED THAT THE THREADING DIMENSIONS ARE SMALL AND BASED ON THE ASSOCIATED TECHNIQUE GUIDES IT IS POSSIBLE THAT THE COMPLAINT CONDITION OCCURRED DUE TO ROUTINE USAGE OVER TIME AND/OR ROUGH HANDLING, WHICH COULD HAVE CAUSED THE THREADING TO WEAR DOWN. ANOTHER POTENTIAL CONTRIBUTING FACTOR IS THE PLATE WHICH WAS BEING USED. IF THE THREADING OF THE PLATE AND/OR THE RETURNED GUIDES WAS COMPROMISED IT COULD HAVE PREVENTED THE GUIDES FROM ENGAGING WITH THE PLATES AS INTENDED. 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 A PROCEDURE, THE SURGEON ATTEMPTED TO THREAD TWO OF THE 1.5MM LOCKING DRILL GUIDES INTO A 2.0MM LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE AND A 2.0MM LOCKING SCREW UNSUCCESSFULLY. THE DEVICES WERE TRIED SEVERAL TIMES. THE SURGERY WAS COMPLETED BY FREE-HANDING THE SCREWS AND WITHOUT FURTHER INCIDENT. THE SURGERY WAS DELAYED TEN (10) MINUTES DUE TO THE NOTED MALFUNCTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED. CONCOMITANT DEVICES REPORTED: 2.0MM LCP CONDYLAR PLATE 7 HOLE (PART 247.349, LOT UNKNOWN, QUANTITY 1); 2.0MM LOCKING SCREW SELF-TAPPING (PART 201.888, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584198 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE GUIDE FZX SYNTHES HAGENDORF 8980903

    Patients

    Seq Age Sex Outcome Treatment
    1 2.0MM LCP CONDYLAR PLATE 7 HOLE (247.349)| 2.0MM LOCKING SCREW SELF-TAPPING (201.888)