BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE/SCREW GUIDE SLEEVE

    MDR report key: 6240909 · Received January 11, 2017

    Report

    Report Number
    9612488-2017-10016
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    UDI-DI
    10886982070333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE 03.037.013 LOT NUMBER 9878418 AIMING ARM AND 03.037.017 LOT NUMBER 9734868C BLADE/SCREW GUIDE SLEEVE WERE RETURNED AND REPORTED TO HAVE BECOME STUCK TOGETHER DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY INTRAOPERATIVE FACTORS SUCH AS PRESSURE FROM SOFT TISSUE; 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 UNCONFIRMED. THE RETURNED 03.037.015 LOT NUMBER 9833846 AIMING ARM LOCKING DEVICE AND 03.037.016 LOT NUMBER 9804211 BUTTRESS COMPRESSION NUT WERE RECEIVED WITHOUT ALLEGATION OR IDENTIFIABLE COMPLAINT CONDITION AND THEREFORE AN INVESTIGATION WILL NOT BE PERFORMED FOR THIS PART. THE 03.037.013 AIMING ARM AND 03.037.017 BLADE/SCREW GUIDE SLEEVE ARE INSTRUMENTS ROUTINELY USED IN THE TFNADVANCED PROXIMAL FEMORAL NAILING SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE BECOME STUCK TOGETHER DURING SURGERY. THIS CONDITION IS UNCONFIRMED; WHILE THE COMPLAINT CONDITION CANNOT BE REPLICATED, DEFORMATION IS APPARENT ON THE GUIDE SLEEVE FROM THE HAMMERING REPORTED TO HAVE BEEN USED TO SEPARATE THE DEVICES. IT IS LIKELY THAT INTRAOPERATIVE FACTORS SUCH AS PRESSURE FROM SOFT TISSUE HAVE LED TO THIS COMPLAINT CONDITION. THE 03.037.017 GUIDE SLEEVE WAS MANUFACTURED IN 7/2016 AND IS LESS THAN A YEAR OLD. THE 03.037.013 AIMING ARM WAS MANUFACTURED IN 4/2016 AND IS LESS THAN A YEAR OLD. THE BALANCE OF EACH OF THE RETURNED DEVICES IS IN OTHERWISE GOOD CONDITION WITH MINIMAL VISIBLE WEAR. RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. PART NUMBER: 03.037.017, SYNTHES LOT NUMBER: 9734868: RELEASE TO WAREHOUSE DATE: JULY 8, 2016. MFG. SITE: (B)(4). 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 THE PATIENT UNDERWENT A TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) PROCEDURE ON (B)(6) 2016 TO TREAT A HIP FRACTURE. THE SURGEON HAD JUST IMPLANTED THE HELICAL BLADE WITHOUT DIFFICULTY AND WAS TRYING TO REMOVE THE BLADE/SCREW GUIDE SLEEVE WHEN IT BECAME STUCK IN THE AIMING ARM. THIS EVENT RESULTED IN A 1 MINUTE SURGICAL DELAY. A MALLET WAS USED TO TAP THE BLADE/SCREW GUIDE SLEEVE WHICH RELEASED IT FROM THE AIMING ARM. NO PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED IN GOOD CONDITION AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: AIMING ARM LOCKING DEVICE: PART # 03.037.015 LOT# 9833846, QUANTITY X 1. BUTTRESS/COMPRESSION NUT: PART #03.037.016 LOT# 9804211, QUANTITY X 1. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25005 BLADE/SCREW GUIDE SLEEVE GUIDE FZX SYNTHES BETTLACH 9734868C 10886982070333

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR AIMING ARM LOCKING DEVICE: PART # 03.037.015| BUTTRESS/COMPRESSION NUT: PART # 03.037.016