BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 5548746 · Received April 5, 2016

    Report

    Report Number
    1719045-2016-10297
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Report Date
    March 22, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 357.372 WITH LOT NUMBER(S) 6852944 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 10, 2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE INNER PIN OF THE ALIGNMENT INDICATOR SHEARED OFF. THE REPAIR TECHNICIAN REPORTED THE PIN IN THE ALIGNMENT NUT SHEARED OFF, THE TOP OF THE INSERTER WAS BURRED AND DAMAGED, THE INSERTER HANDLE WAS MARKED AND SCRATCHED, AND THE ALIGNMENT BALLS NEAR THE FRONT OF THE INSTRUMENT WERE WORN AND FLATTENED. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: PHOTOGRAPHS OF THE DEVICE WERE FORWARDED TO CUSTOMER QUALITY WHERE THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH ROUGH HANDLING AND IMPACTION OF THE ALIGNMENT INDICATOR. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, SERVICE EVALUATION, COMPLAINT/SERVICE HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. PER THE TECHNIQUE GUIDE, THE HELICAL BLADE INSERTER IS A COMPONENT OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. A COUPLING SCREW IS PASSED THROUGH THE INSERTER AND THREADED INTO THE HELICAL BLADE FORMING AN ASSEMBLY. THE INSERTER IS THEN PASSED THROUGH A BLADE GUIDE SLEEVE AND ADVANCED USING ¿LIGHT HAMMER BLOWS¿ TO THE BACK OF THE COUPLING SCREW. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WAS EXAMINED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL AND ALIGNMENT INDICATOR. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT'S LOT NUMBER AND NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CORRECTED DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: JEN INSTRUMENTS. MANUFACTURING DATE: JANUARY 10, 2012. PART: 357.372, LOT: 6852944 (NON-STERILE) - HELICA BLADE INSERTER. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JANUARY 10, 2012. PART 357.369, LOT 5060074: A MATERIAL REVIEW REPORT WAS ISSUED FOR FAIL GO GAGE. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT PART OF THE TROCHANTERIC FIXATION NAIL (TFN) HELICAL BLADE HAS THE SMALL PIN ON IT SHEARED OFF. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203624 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6852944

    Patients

    Seq Age Sex Outcome Treatment
    1