BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTI VECTOR DISTRACTOR BODY

    MDR report key: 3081848 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11148
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 22, 2012
    Report Date
    March 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    PMA / PMN Number
    K981362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE VISUAL INSPECTION PERFORMED AS PART OF THE PRODUCT EVALUATION REVEALED THE PIN WAS MISSING AND REQUESTED FURTHER EVALUATION BY MANUFACTURING. MANUFACTURING INSPECTION CONFIRMED THE PIN HOLE WAS OUT OF SPECIFICATION AS STATED IN THE PRODUCT EVALUATION, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    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 PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE REPORT INDICATED THAT THE RETURNED DEVICE (PART NUMBER: 487.931, LOT NUMBER: 3808871) WAS MISSING THE 1.5MM PIN ON ONE SIDE AS STATED IN THE COMPLAINT DESCRIPTION. THE AREAS OF THE COUPLERS THAT MATE WITH THE DISTRACTOR ARMS SHOW SOME SCRATCHES AND MINOR WEAR. THERE IS A MINOR SCRATCH DOWN FACE OF THE PART WHERE THE PART AND LOT NUMBERS ARE LASER ETCHED. USING THE APPROPRIATE ANGULAR ADJUSTMENT INSTRUMENT (PART NUMBER: 387.423, LOT NUMBER: 5470720), BOTH ANGLES OF THE DISTRACTOR BODY COULD BE ADJUSTED EASILY. OTHER THAN THE MISSING PIN, THE DEVICE FUNCTIONS AS EXPECTED. THE DESIGN RISK ASSESSMENT INCLUDES A THOROUGH TOLERANCE STACK ANALYSIS. ONE OF THESE TOLERANCE STACKS ADDRESSES THE PRESS FIT OF THE 1.5MM PIN INTO THE CORRESPONDING HOLE IN THE WORM GEAR SEGMENT WITH A U-JOINT HUB (PART NUMBER: 487.931.8) AND SHOWS THAT THERE WILL BE GUARANTEED INTERFERENCE IF THE PARTS ARE MADE TO THE DRAWINGS. THE PRESS FIT TO HOLD THE 1.5MM PIN WAS DESIGNED WITH AN ADEQUATE AMOUNT OF INTERFERENCE. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE. CONCLUSION ¿ AS THE REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT, THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE COMPLAINT IS ALSO CONSIDERED TO BE INVALID AS THE EVALUATION OF THE PART INDICATED THAT OTHER THAN THE MISSING PIN, THE DEVICE FUNCTIONS AS EXPECTED AND THE DESIGN RISK ASSESSMENT REVEALED THAT THE PART WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH DISTRACTOR BODY FOR AIRWAY OBSTRUCTION ON (B)(6) 2012. THE SHEER PIN WAS MISSING ON THE ONE SIDE OF THE CONSTRUCT. THE SHEER PIN IS NEEDED FOR DISTRACTING. SURGEON PLANS ON REMOVING THE DISTRACTOR BODY AND REPLACING WITH A NEW DISTRACTOR BODY ON (B)(6) 2012 AT THE PATIENT'S BEDSIDE. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184947 TI MULTI VECTOR DISTRACTOR BODY DZL SYNTHES GMBH 3808871

    Patients

    Seq Age Sex Outcome Treatment
    1