BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTMENT KNOB FOR SURELOCK ANTEGRADE FEMORAL NAILS

    MDR report key: 5407653 · Received February 3, 2016

    Report

    Report Number
    2520274-2016-10724
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Report Date
    January 15, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE FOLLOWING COMPLAINT DEVICE WAS RECEIVED: ONE ADJUSTMENT KNOB FOR SURELOCK ANTEGRADE FEMORAL NAILS (PART NUMBER: 03.010.203, LOT NUMBER: 1800285). THE ADJUSTMENT KNOB FOR SURELOCK ANTEGRADE FEMORAL NAILS IS PART OF THE DEPUY SYNTHES SURELOCK DISTAL TARGETING DEVICE SYSTEM. THE SYSTEM IS DESIGNED TO FACILITATE, DISTAL LOCKING OF SYNTHES TITANIUM TROCHANTERIC FIXATION NAILS. THE ADJUSTMENT KNOB ENSURES THE AIMING ARM IS STRAIGHT. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE THERE IS VISIBLE DAMAGE THROUGHOUT THE BODY PORTION OF THE DEVICE AN INDICATION THE DEVICE MAY HAVE EXPERIENCED ROUGH HANDLING. THE SHAFT PORTION OF THE DEVICE APPEARS TO BE IN GOOD CONDITION. THE TWO COMPONENTS WERE ABLE TO BE PULLED APART AND IT CAN BE SEEN THAT THE PIN THAT HOLDS THE INSTRUMENT TOGETHER HAS BROKEN OFF RESULTING IN THE COMPLAINT DESCRIPTION. A ROOT CAUSE COULD NOT BE DETERMINED; A POSSIBLE CAUSE WAS THE DEVICE WAS DISASSEMBLED FOR STERILIZATION AND IN THE PROCESS THE PIN BROKE. THE COMPLAINT IS CONFIRMED. 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. RECEIPT DATE OF LOT NUMBER WAS (B)(4) 2016. 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

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28 DECEMBER 2010, NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DATE UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. 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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. 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 PART NUMBER 03.010.203 WAS BROKEN INTO 2 PIECES. THE PIN THAT KEEPS THEM TOGETHER HAS BROKEN. THIS COMPLAINT WAS DISCOVERED IN SPD AND NOT IN THE OPERATING ROOM. NO ADDITIONAL INFORMATION PROVIDED. THE ADJUSTMENT KNOB HAS BEEN BROKEN INTO 2 PIECES, DATE OF EVENT IS UNKNOWN AS THE PIECES WERE DISCOVERED BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO ADDITIONAL INFORMATION TO PROVIDE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65011 ADJUSTMENT KNOB FOR SURELOCK ANTEGRADE FEMORAL NAILS GUIDE FZX SYNTHES HAGENDORF 1800285

    Patients

    Seq Age Sex Outcome Treatment
    1