BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM/8.0MM PROTECTION SLEEVE153MM

    MDR report key: 6836638 · Received August 31, 2017

    Report

    Report Number
    2530088-2017-10264
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Report Date
    August 9, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    UDI-DI
    10886982196132
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT REPORTED. 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 DHR HAS BEEN REQUESTED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 357.386, SYNTHES LOT # 5058562. RELEASE TO WAREHOUSE DATE: 18-JAN-2006. EXPIRATION DATE: NA. MANUFACTURED BY: (B)(4). 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. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (11.0MM/8.0MM PROTECTION SLEEVE153MM, PART NUMBER 357.386, LOT NUMBER 5058562). THE 357.386, LOT NUMBER 5058562, 11.0MM/8.0MM PROTECTION SLEEVE 153MM WAS RETURNED WITH BENT EDGES ON THE DISTAL END. THE EDGES ARE BENT TOWARDS THE CENTER OF AXIS OF THE INSERTION HOLE, WHICH PREVENTS THE 357.389 DRILL SLEEVE FROM FULLY ENGAGING WITH AND PASSING THROUGH THE PROTECTION SLEEVE. THIS COMPLAINT AGAINST THE PROTECTION SLEEVE IS CONFIRMED. THE 357.387, LOT NUMBER 5171129, 4.0MM TROCAR 176MM WAS RETURNED WITH A BENT SHAFT. THE BENT SHAFT CAUSES RESISTANCE WHEN ENGAGING WITH THE 357.389 DRILL SLEEVE. THIS COMPLAINT AGAINST THE TROCAR IS CONFIRMED. THE 357.389, LOT NUMBER 5133403, 8.0MM/4.0MM DRILL SLEEVE 164MM WAS RETURNED WITH NO MALFUNCTIONS OR DEFECTS FOUND WHICH POTENTIALLY AFFECTS THE FUNCTION OF THE DEVICE OR COMPLAINT CONDITION. THE INSTRUMENT WAS NOT OBSERVED TO BE BENT. THE COMPLAINT AGAINST THE DRILL SLEEVE IS UNCONFIRMED AS THE DEVICE INTERACTION COMPLAINT CAUSE IS ISOLATED TO THE PROTECTION SLEEVE AND TROCAR. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT WAS ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ), WHEN ENGAGING ALL THREE INSTRUMENTS, THE DEVICES STICK/JAM DUE TO THE MALFUNCTIONS OBSERVED ON THE PROTECTION SLEEVE AND TROCAR. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO ROUGH HANDLING DURING SURGERY/STERILE PROCESSING AND/OR CONSISTENT USE AND CUMULATIVE WEAR OVER THE PART¿S LIFETIME. 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 ONE (1) PROTECTION SLEEVE, ONE (1) DRILL SLEEVE AND ONE (1) TROCAR SEEM TO BE BENT AND HAVE STARTED STICKING TOGETHER DUE TO WEAR AND TEAR OVER TIME, THUS NEEDING REPAIR. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS FOR ONE DEVICES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615676 11.0MM/8.0MM PROTECTION SLEEVE153MM GUIDE FZX SYNTHES BRANDYWINE 5058562 10886982196132

    Patients

    Seq Age Sex Outcome Treatment
    1