BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE CERVICAL DISTRACTOR-RIGHT

    MDR report key: 5853232 · Received August 8, 2016

    Report

    Report Number
    9680938-2016-10120
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    June 16, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE DHR IS NO LONGER AVAILABLE DUE TO THE AGE OF THE INSTRUMENT (OVER 10 YEARS OLD). PART NUMBER 396.396 WITH LOT NUMBER(S) A7OA23/5032364 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 28-JUN-2005. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE REPAIR TECHNICIAN REPORTED THE ARM ON THE DISTRACTOR WAS BROKEN AND MISSING PARTS. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE PRODUCT EVALUATION SHOWS, IT WAS REPORTED THAT THE DISTRACTORS HAD BROKEN ARMS. THE DISTRACTORS WERE FORWARDED TO SERVICE AND REPAIR WHERE THE TECHNICIAN WHERE IT WAS CONFIRMED THAT THE PARTS WERE DAMAGED, BROKEN, AND MISSING COMPONENTS. EACH DISTRACTOR HAD A BROKEN ARM WITH ALL BUT LOT A7PA10 MISSING SOME FRAGMENTS. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE AS THE PARTS WERE RETURNED BROKEN AND BENT. A VISUAL INSPECTION, FUNCTIONAL TEST, (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. AS THE CIRCUMSTANCES LEADING TO THE DAMAGE IS NOT KNOWN, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER, THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE OVER THE COURSE OF USE. THE ADJUSTABLE CERVICAL DISTRACTORS (396.395-.396) ARE NOTED IN INSTRUMENTS TECHNIQUE GUIDES. THE DISTRACTORS ARE UTILIZED FOR INTERVERTEBRAL DISTRACTION FOR ANTERIOR CERVICAL APPLICATIONS. THE RETURNED DISTRACTORS WERE EXAMINED AND THE COMPLAINT WAS ABLE TO BE CONFIRMED AS EACH DISTRACTOR HAD A BROKEN ARM WITH ALL BUT LOT A7PA10 MISSING SOME FRAGMENTS. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: JOINT AND PIN. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. THE DHR WAS PERFORMED FOR THE RETURNED INSTRUMENT'S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION FOR THE DHRS THAT WERE ABLE TO BE CONDUCTED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE DISTRACTION FORCE. AS THE CIRCUMSTANCES LEADING TO THE DAMAGE IS NOT KNOWN, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER, THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE OVER THE COURSE OF USE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. 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 ROUTINE INSPECTION SIX (6) MALFUNCTIONED INSTRUMENTS WERE FOUND. THERE WERE TWO (2) T-HANDLE T25 STARDRIVE SHAFTS WITH WORN TIPS, TWO (2) RIGHT ADJUSTABLE CERVICAL DISTRACTORS WITH BROKEN ARMS AND TWO (2) LEFT ADJUSTABLE CERVICAL DISTRACTORS WITH BROKEN ARMS. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THIS REPORT IS 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507195 ADJUSTABLE CERVICAL DISTRACTOR-RIGHT MISC ORTHO SURGICAL INSTR LXH SYNTHES TUTTLINGEN 5032364

    Patients

    Seq Age Sex Outcome Treatment
    1