BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 6213921 · Received December 29, 2016

    Report

    Report Number
    9612488-2016-10530
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 4, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    UDI-DI
    10886982068965
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.475, LOT# 9105449. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 03, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 03.010.475 LOT NUMBER 9105449 DRIVING CAP WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER TWO YEARS OF CONSISTENT USE AND POSSIBLY ANGLED HAMMER BLOWS DURING SURGERY; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE RETURNED 03.010.440 LOT NUMBER 160187-101 INSERTION HANDLE FOR SUPRAPATELLAR WAS RECEIVED AS A CONCOMITANT DEVICE WITHOUT ALLEGATION OR IDENTIFIABLE COMPLAINT CONDITION AND THEREFORE AN INVESTIGATION WILL NOT BE PERFORMED FOR THIS PART. PER THE TECHNIQUE GUIDE, THE 03.010.475 DRIVING CAP IS AN INSTRUMENT ROUTINELY USED IN THE SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TIBIAL NAILS. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THE DISTAL THREADED TIP OF THE DRIVING CAP HAS SHEARED OFF THE SHAFT OF THE DEVICE AND IS LODGED INSIDE THE INSERTION HANDLE. IT IS LIKELY THAT OVER TWO YEARS OF CONSISTENT USE AND POSSIBLY ANGLED HAMMER BLOWS DURING SURGERY HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN OCTOBER 2014 AND IS OVER TWO YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIRLY GOOD CONDITION DESPITE MARKINGS FROM HAMMER BLOWS AT THE PROXIMAL END CONSISTENT WITH PROPER USAGE. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NON-CONFORMANCE REPORTS GERMANE TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 A SUPRAPATELLAR TIBIA NAIL PROCEDURE THAT TOOK PLACE ON (B)(6) 2016, DUE TO THE PATIENT PRESENTING WITH A TIBIAL FRACTURE FROM A MOTOR CYCLE ACCIDENT ON THE UNKNOWN DATE, THE DRIVING CAP INSTRUMENT THREADS BROKE OFF INSIDE THE INSERTION HANDLE INSTRUMENT. THE INSERTION HANDLE WAS NOT BROKEN, HOWEVER PART OF DRIVING CAP WHICH THREADS INTO THE INSERTION HANDLED IS LODGED INSIDE THE HANDLE. NO FRAGMENTS WERE GENERATED. DUE TO THIS EVENT AN ADDITIONAL FIVE MINUTES WAS ADDED TO OPERATING ROOM TIME. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT MEDICAL PRODUCTS: 11MM TI CANNULATED TIBIAL NAIL (PART #04.034.552S, LOT # UNKNOWN, QTY.1); INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440, LOT # 160187-101, QTY 1.) THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862957 DRIVING CAP MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 9105449 10886982068965

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR PART# 03.010.440, LOT# 160187-101, QUANTITY 1| PART# 04.034.552S, LOT# UNKNOWN, QUANTITY 1