BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 5135995 · Received October 8, 2015

    Report

    Report Number
    2520274-2015-16497
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Report Date
    September 26, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. S&R SERVICE HISTORY REVIEW HAS BEEN REQUESTED. 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

    SERVICE HISTORY REVIEW: PART NO: 351.16J, LOT NO: 8053605 CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. SERVICE HISTORY REVIEW: PART NO: 351.16J, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 12-SEP-2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ADAPTER WOULD NOT HOLD THE REAMING SHAFT. THE REPAIR TECHNICIAN REPORTED THE CHUCK PIN WAS MISSING. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE INSTRUMENT WAS RECEIVED ASSEMBLED AND UPON VISUAL INSPECTION OF THE DEVICE IT APPEARED THAT ONE OF THE GUIDE PINS WAS MISSING FROM THE CONNECTOR, THE COMPLAINT DEVICE WAS THEN DISASSEMBLED AND IT WAS CONFIRMED THAT THE ONE OF THE GUIDE PINS WAS MISSING FROM THE DEVICE PREVENTING IT FROM FUNCTIONING AS INTENDED. THE RETURNED CONDITION IS CONSISTENT WITH HAVING BEEN DISASSEMBLED. EVEN THOU THE SET SCREW IS LOCTITE IN PLACE TO PREVENT DISASSEMBLY, IT IS A COMMON PRACTICE FOR A DEVICE TO BE DISASSEMBLED BY FORCE, IF POSSIBLE, FOR CLEANING/REPROCESSING. THUS, WHILE IT CANNOT BE DEFINITIVELY DETERMINED, IT IS MOST PROBABLE THAT DISASSEMBLY FOR CLEANING, AND SUBSEQUENT LOSS OF THE PINS AND/OR IMPROPER REASSEMBLY OF THE DEVICE LED TO THE COMPLAINT CONDITION. PER THE TECHNIQUE GUIDE, THE FLEXIBLE SHAFT HANDLE IS PART OF THE FLEXIBLE REAMER SETS AND USED IF REAMING OF THE MEDULLARY CANAL IS DESIRED FOR IMPLANTATION OF RETROGRADE/ANTEGRADE FEMORAL NAILS (R/AFN), LATERAL FEMORAL NAILS (LFN), AND CANNULATED TIBIAL NAILS. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE MANUFACTURED REVISION WAS PERFORMED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THIS FAILURE MODE IS TYPICALLY ASSOCIATED WITH LOST PARTS AS A RESULT OF DISASSEMBLY DURING STERILIZATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED 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.

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT REPORTED THAT THE FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK, ADAPTER WOULD NOT HOLD THE REAMING SHAFT. IT KEPT DISCONNECTING WHILE THE SURGEON WAS REAMING BACK OUT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A FIVE (5) MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665897 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER HTO SYNTHES BETTLACH 8053605

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR