BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.0MM CANN FLEXIBLE DRILL BITLARGE QC/310MM

    MDR report key: 3083306 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11183
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 5, 2012
    Report Date
    July 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE DRILL BIT SHAFT BROKEN AT MOST PROXIMAL END OF HELICAL SIGMOID LASER CUT. WITH THE LIMITED AMOUNT OF INFORMATION AND NO PREVIOUS COMPLAINTS THIS COMPLAINT WAS FOUND TO BE INDETERMINATE FROM A DESIGN STANDPOINT. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. THIS COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. THE MANUFACTURING EVALUATION OF THE PRODUCT REVEALED THE SHAFT OF THE CUTTER BROKE AT THE FIRST SLOTTED LEVEL. THE SHAFT DID NOT FELL APART; BOTH PARTS ARE STILL WEDGED INTO EACH OTHER. THE DEVICE SHOWS MARKS OF OFTEN OR FORCIBLE USE. THE CUTTING BLADES ON THE REAMER HEAD ARE BLUNT AND DO SHOW MARKS AND BURRS. THE BURRS ON THE CUTTING BLADES ON THE REAMER HEAD POINT TO THE FACT THAT THE INSTRUMENT WAS USED ANTI-CLOCKWISE DURING THE OPERATION. THE DEVICE HISTORY RECORD REVIEW SHOWS THAT THE CORRECT MATERIAL AND HARDENING PROCEDURES WERE USED. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED DURING OPERATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND WAS NOT IMPLANTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SEGMENTAL FEMUR FRACTURE PROCEDURE, THE 15MM CANNULATED FLEXIBLE DRILL BIT BROKE WITH NO UNDUE STRESS PUT ON THE INSTRUMENT AT ONE OF THE PROXIMAL FLEXIBLE LINKS. THERE WAS NO REPORTED HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185477 15.0MM CANN FLEXIBLE DRILL BITLARGE QC/310MM HTW SYNTHES GMBH 2360754

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR