BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    MDR report key: 6547808 · Received May 5, 2017

    Report

    Report Number
    3003875359-2017-10217
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 16, 2017
    Report Date
    April 16, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982069047
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM (PART# 03.010.486 LOT# L027182), ONE RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN (PART# 03.010.482 LOT# T989153), AND ONE CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE (PART# 03.010.146 LOT# U180796) WERE RECEIVED AT CUSTOMER QUALITY (CQ) FOR EVALUATION WITH COMPLAINT CATEGORY DEVICE INTERACTION: MISALIGNMENT AND WITH THE COMPLAINT DESCRIPTION. DRAWINGS FOR THE DEVICE WERE REVIEWED, AND NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION: A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS UNCONFIRMED, AS THE CONSTRUCT WAS REASSEMBLED; HOWEVER NOT ALL DEVICES INVOLVED IN THE COMPLAINT WERE RETURNED FOR INVESTIGATION THEREFORE, BEING UNABLE TO RECREATE THE COMPLAINT CONDITION. ADDITIONALLY, OTHER VARIABLES COULD HAVE CONTRIBUTED TO THE DRILL BIT NOT ALIGNING CORRECTLY DURING THE PROCEDURE, SUCH AS THE PATIENT¿S CONDITION AND PHYSICAL ATTRIBUTES, OR LATERAL FORCES ON THE CONSTRUCT COULD HAVE IMPACTED THE POSITIONING OF THE LOCKING INSTRUMENTATION OR LATERAL FORCES DURING SURGERY, THAT ARE UNABLE TO BE REPLICATED IN THE CQ, MAY HAVE BEEN ACTING ON THE CONSTRUCT DUE TO THE TIGHT TOLERANCES AND DESIGN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT SOFT TISSUE DISTRACTIONS FORCES ARE THE CAUSE OF THIS COMPLAINT CONDITION; IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION.. THE INSTRUMENTS ARE A PART OF THE EXPERT LATERAL FEMORAL NAIL (LFN) SYSTEM AND ARE USED FOR ALIGNING THE NAIL WITH THE INTRAMEDUALLY CANAL DURING THE INSERTION AND EXTRACTION OF THE LATERAL FEMORAL NAIL. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A CANNULATED CONNECTION SCREW (PART NUMBER 03.010.146 AND LOT NUMBER U109603) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. DEVICE 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: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 19.SEP.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.

    Description of Event or Problem · 1

    ON 18JUN2017 UPDATE: A CANNULATED CONNECTION SCREW (PART NUMBER 03.010.146 AND LOT NUMBER U109603) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO STATICALLY LOCK THE NAIL DURING A LATERAL ENTRY FEMORAL NAIL PROCEDURE ON (B)(6) 2017. PRIOR TO INSERTING THE NAIL THE ALIGNMENT DEVICES WERE WORKING CORRECTLY; HOWEVER, WHEN THE TROCAR WAS IN PLACE AND THE SURGEON WAS DRILLING, THE DRILL BIT HIT THE TOP PORTION OF THE HOLE OF THE NAIL AND THE SURGEON WAS UNABLE TO DRILL THROUGH THE HOLE. THERE WAS A 3 TO 5 MINUTE SURGICAL DELAY AS THE SURGEON TRIED TO TROUBLESHOOT THE AIMING DEVICE. THE SURGEON DECIDED TO DYNAMICALLY LOCK THE NAIL AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS FINE. CONCOMITANT DEVICES REPORTED: NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); TROCAR (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION (PART 03.010.061, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329800 RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF L027182 10886982069047

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BIT (03.010.061, LOT UNKNOWN, QTY 1)| TROCAR (PART AND LOT UNKNOWN, QTY 1)