BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE

    MDR report key: 3083469 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10921
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    September 19, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. TWO PRODUCTS WERE RETURNED FOR A MANUFACTURING EVALUATION, SERIAL NUMBERS (B)(4). A CRUSHED FERRULE WAS RETURNED IN THE TIP ON THE (B)(4) DEVICE. THE (B)(4) DEVICE HAD DENTS AND SCRATCHES ON ALL SURFACES INDICATING USE. THE (B)(4) DEVICE ALSO HAD DENTS AND SCRATCHES, BUT MORE SEVERE, INDICATING ABUSE. BOTH TIPS ROTATED AND RETRACTED AS INTENDED, AND THE WHEEL SPUN FREELY IN A COUNTER-CLOCKWISE DIRECTION AS INTENDED. THE (B)(4) DEVICE CLUTCH SETTING WAS UNDER SPECIFICATION AND THE (B)(4) DEVICE CLUTCH SETTING WAS OVER SPECIFICATION. BOTH DEVICES CRIMPED THE FERRULE AND CUT THE WIRE AS INTENDED (NO PREMATURE CUTTING); THE CRIMP STRENGTH WAS WITHIN PRINT SPECIFICATION. THE CUTTER WAS POSITIONED PROPERLY AS IDENTIFIED BY THE FERRULE SEATING PROPERLY IN THE TIP DURING THE FUNCTIONAL TESTING AND PASSED A FUNCTION TEST WITH A GAGE. THE KNOB ROTATION ON THE (B)(4) DEVICE SEEMED TO SLIP AND NOT DISTINCTLY LOCK IN THE DETENTS. COMPARING THE TWO DEVICES, THE (B)(4) DETENT COUNTERSINK AND THRU HOLE WERE SMALLER THAN THE (B)(4) DEVICE. THE CLUTCH SETTING VALUES WOULD NOT CAUSE THE CABLE TO BREAK; THE BREAKING CONCERN IN THIS COMPLAINT COULD NOT BE VERIFIED. THE CONCERN THAT THE WHEEL IS BLOCKED CAUSING THE CABLE TO BREAK ALSO COULD NOT BE CONFIRMED. THE OUT OF TOLERANCE CLUTCH SETTINGS AND LOCKING DETENT COULD CONTRIBUTE TO THE APPEARANCE OF NON-OPTIMAL ROTATION. THERE IS NO RECORD OF THIS DEVICE BEING SERVICED OR RE-CALIBRATED. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. A CAPA RISK ASSESSMENT WAS COMPLETED FOR THE IDENTIFIED NON-CONFORMANCE. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.THIS REPORT IS FOR TWO TENSIONER INSTRUMENTS FOR STERNAL CABLE, THE DEVICES WERE FROM THE SAME PART NUMBER AND LOT NUMBER.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AFTER OBTAINING A REDUCTION WITH 3 FORCEPS AND PLACING 5 CABLES ON A PATIENT, THE SURGEON TOOK THE FIRST INSTRUMENT AND TRIED TO TENSION THE CABLE. THE CABLE BROKE 3 TIMES. HE TRIED THE SECOND INSTRUMENT WITH THE SAME RESULT. IT APPEARED THAT THE PART OF THE INSTRUMENTS WHICH ARE SUPPOSED TO ROTATE IN ORDER TO TENSION THE CABLES WAS BLOCKED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185725 TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE LXH SYNTHES (USA) 6652276

    Patients

    Seq Age Sex Outcome Treatment
    1