BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 6499915 · Received April 18, 2017

    Report

    Report Number
    3003787298-2017-10000
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10886982196064
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. 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). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART # PART # 357.372 LOT # 7240662. NO NCR'S 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. RELEASE TO WAREHOUSE DATE: 31 JAN 2013. MANUFACTURED BY SYNTHES (B)(4). 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

    SUBJECT DEVICE HAS BEEN RECEIVED AT CQ AND A PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED: A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED DEVICE AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. VISUAL INSPECTION AT CQ: THIS COMPLAINT IS CONFIRMED. THE ALIGNMENT PIN ON THE PROXIMAL ALIGNMENT INDICATOR COMPONENT HAS BECOME DEFORMED. THE THUMB SCREW IS DAMAGED AND DIFFICULT TO TIGHTEN AND LOOSEN. AS A RESULT, THE ALIGNMENT INDICATOR COMPONENT NOW SPINS FREELY ABOUT THE REMAINDER OF THE DEVICE. SEVERAL HAMMER MARKS EXIST ON THE PROXIMAL ALIGNMENT INDICATOR COMPONENT AND ONE OF THE EARS IS BENT DISTALLY. NOTE: VISUAL INSPECTION UNDER 5X MAGNIFICATION SUGGESTS THAT THE PIN IS SHORTER (DEFORMED BUT NOT BROKEN). THIS COMPLAINT WAS MOST LIKELY CAUSED BY INADVERTENT HAMMER BLOWS THAT MISSED THE HELICAL BLADE COUPLING SCREW AND DAMAGED THIS DEVICE. PER THE COMPLAINT DESCRIPTION "REPORTEDLY, THE SURGEON HIT THE HELICAL BLADE INSERTER MANY TIMES WITH THE HAMMER AND ONE SWING OF THE HAMMER STRUCK THE "T" ON THE HANDLE CAUSING THE CUTTER PIN IN THE "T" TO SHORTEN. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. "NO IDENTIFICATION OR EVIDENCE OF A FRAGMENT WAS REPORTED OR CONFIRMED, THEREFORE THE FAILURE CODE OF "MALFORMED : BENT/DISTORTED/ WARPED" WAS SELECTED FOR THIS INVESTIGATION SUMMARY. 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

    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) REPORTS AN EVENT AS FOLLOWS: IT IS REPORTED THAT DURING A PROXIMAL FEMUR FRACTURE REPAIR USING A TROCHANTERIC FIXATION NAIL (TFN), A HELICAL BLADE WAS DIFFICULT TO INSERT IN THE FEMUR DUE TO AN OVER TIGHTENED COMPRESSION NUT. THE OVER TIGHTENED NUT SEEMED TO HAVE CAUSED MISALIGNMENT OF THE GUIDE WIRE. REPORTEDLY, THE SURGEON HIT THE HELICAL BLADE INSERTER MANY TIMES WITH THE HAMMER AND ONE SWING OF THE HAMMER STRUCK THE "T" ON THE HANDLE CAUSING THE CUTTER PIN IN THE "T" TO SHORTEN. IT IS UNCLEAR IF THE CUTTER PIN FELL APART OR NOT AND IT IS UNKNOWN IF FRAGMENTS WERE GENERATED; NO FRAGMENTS WERE NOTED. THE "T" NOW ROTATES FREELY AROUND THE HANDLE AND NOW IS NOTABLY HARD TO SCREW. THERE WAS A SURGICAL DELAY OF LESS THAN 5 MINUTES. THE SURGERY WAS COMPLETED WITH THE SAME T-HANDLE AS IT WAS STILL USABLE. WHILE THE DEVICE WAS BEING USED SPECIAL CARE WAS TAKEN TO ENSURE THE HANDLE SAT ON THE SLEEVE WHILE IMPACTING THE BLADE TO CONFIRM FINAL POSITIONING. REPORTEDLY, THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE IS NO PATIENT INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: GUIDE WIRE, TROCHANTERIC FIXATION NAIL (QUANTITY 1), HELICAL BLADE (QUANTITY 1), CONNECTING SCREW (QUANTITY 1), BUTTRESS/COMPRESSION NUT (QUANTITY 1), HAMMER (QUANTITY 1), BLADE GUIDE SLEEVE (QUANTITY 1), STEPPED DRILL BIT (QUANTITY 1), DRILL STOP (QUANTITY 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280998 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 7240662 10886982196064

    Patients

    Seq Age Sex Outcome Treatment
    1 BUTTRESS NUT (PART AND LOT UNKNOWN, QTY 1)| CONNECTING SCREW (PART AND LOT UNKNOWN, QTY 1)| DRILL BIT (PART AND LOT UNKNOWN, QTY 1)| DRILL STOP (PART AND LOT UNKNOWN, QTY 1)| GUIDE SLEEVE (PART AND LOT UNKNOWN, QTY 1)| GUIDE WIRE (PART AND LOT UNKNOWN, QTY UNKNOWN)| HAMMER (PART AND LOT UNKNOWN, QTY 1)| HELICAL BLADE (PART AND LOT UNKNOWN, QTY 1)| TFN (PART AND LOT UNKNOWN, QTY 1)