BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT

    MDR report key: 6515224 · Received April 24, 2017

    Report

    Report Number
    9680938-2017-10068
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Report Date
    March 28, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXP
    UDI-DI
    10887587011677
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. A CORNER OF THE DISTAL LEDGE THAT ALIGNS PLATES HAS SHEARED OFF OF ONE OF THE JAWS. THE SHEARED OFF FRAGMENT WAS NOT RETURNED. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. THE RETURNED MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT ARE A REUSABLE INSTRUMENT IN THE MATRIX MANDIBLE PLATING SYSTEM USED TO AID IN CONTOURING PLATES TO FIT PATIENT ANATOMY. RELEVANT DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. IT IS MOST LIKELY THE RESULT OF CUMULATIVE WEAR FOR THIS 7 YEAR OLD REUSABLE BENDING PLIER. 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. THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. (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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER T944992. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 01-APR-2010. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT WHILE PERFORMING A ROUTINE INSPECTION OF THE SET, IT WAS NOTICED THAT THERE IS A LITTLE CHIP MISSING OUT OF ONE OF THE TEETH IN THE MATRIXMANDIBLE PLATE BENDING PLIERS, LEFT. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298781 MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT INSTR,BENDING OR CONTOURING HXP SYNTHES TUTTLINGEN T944992 10887587011677

    Patients

    Seq Age Sex Outcome Treatment
    1