BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 5409931 · Received February 4, 2016

    Report

    Report Number
    1719045-2016-10107
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 18, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT ALL THREE DEVICES HAVE A BROKEN PIN WHICH HOLDS THE ALIGNMENT INDICATOR IN THE CORRECT POSITION. THE ALIGNMENT INDICATOR SPINS FREELY ABOUT THE SHAFT OF THE DEVICE: COMPLAINT CONDITION FOR THE THREE 357.372 HELICAL BLADE INSERTERS WITH LOT NUMBERS 6192984, 4887875, AND 6104566 AND TWO 357.392 17.0MM/3.2MM WIRE GUIDE WITH LOT NUMBERS 5218039 AND 5499000 WERE LIKELY CAUSED BY NUMEROUS YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO FUNCTIONAL PRODUCT ISSUE WAS IDENTIFIED UPON EXAMINATION OF THE THREE RETURNED 357.410 22.0MM/17.0MM PROTECTION SLEEVES WITH LOT NUMBERS 4843007, 4972075, AND 6060711, THREE 357.411 INSERTION HANDLES WITH LOT NUMBERS 7416630, 4826269, AND 7416630, THREE 357.395 DRIVING CAPS WITH LOT NUMBERS 3024236, 5263284, AND 5036679, THREE 357.377 HELICAL BLADE COUPLING SCREWS WITH LOT NUMBERS IS10244, 7935422, AND IS10279, THREE 357.366 AIMING ARMS WITH LOT NUMBERS 8607868, 8236557, AND 3747218, THE 357.392 17.0MM/3.2MM WIRE GUIDE WITH LOT NUMBER 4830099, OR THE 357.378 HELICAL BLADE EXTRACTOR WITH UNKNOWN LOT NUMBER. THIS CONDITION IS CONFIRMED. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART# 357.372 LOT# 6104566 RELEASE TO WAREHOUSE DATE: (B)(6) 2009 SUPPLIER- (B)(6) MEDICAL. NO 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 FOLLOWING SUBCOMPONENT DHRS WAS REVIEWED: 357.372.3 LOTS 6071678 AND 6077677. THERE WERE NO ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    (B)(4).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

    (B)(4).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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE AND REPAIR EVALUATION WAS ATTEMPTED: SERVICE HISTORY REVIEW: PART NO.357.372, LOT NO: 6104566 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 17-MAR-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    PRODUCT EVALUATION: IT IS LIKELY THAT NUMEROUS YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. LOT NUMBER 5499000 WAS MANUFACTURED IN 5/2007 AND IS OVER EIGHT YEARS OLD. LOT NUMBER 5218039 WAS MANUFACTURED IN 5/2006 AND IS OVER NINE YEARS OLD. THE BALANCE OF EACH OF THE RETURNED DEVICES IS IN FAIRLY WORN CONDITION WITH NUMEROUS MARKINGS ALONG THEIR LENGTH. THE DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED 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 AN INSPECTION OF A TRAY OF DEVICES STORED AT THE HOSPITAL, THE REPORTED NOTED A NUMBER OF BROKEN OR DAMAGED DEVICES. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67912 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BRANDYWINE 6104566

    Patients

    Seq Age Sex Outcome Treatment
    1