BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE COMBINATION BENDER

    MDR report key: 5686344 · Received May 27, 2016

    Report

    Report Number
    2520274-2016-12915
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER T934907. 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 SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE MANUFACTURE DATE. CORRECTED DATA: LOT NUMBER AND UDI. STREET ADDRESS. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    CLARIFICATION: PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. PRODUCT INVESTIGATION SUMMARY: ONE (1) MATRIXMANDIBLE COMBINATION BENDER (PART: 03.503.056 / LOT: T934907) WAS RECEIVED FOR EVALUATION WITH THE COMPLAINT CATEGORY "BROKEN: INTRAOPERATIVELY." THIS COMPLAINT IS CONFIRMED AS THE RETURNED DEVICE WAS RECEIVED IN TWO (2) PIECES (PORTION OF THE LEAF SPRING COMPONENT IS SHEARED OFF AND IS SEPARATE FROM REMAINDER OF BENDING INSTRUMENT). THE LEAF SPRING SHEARED OFF APPROXIMATELY 25MM FROM THE LOCATION WHERE IT IS SECURED TO THE HANDLE WITH A SCREW. THE SHEARED OFF SECTION OF THE LEAF SPRING IS APPROXIMATELY 50MM IN LENGTH. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE MANUFACTURER IS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY EXCESSIVE FORCE. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. 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. A REVIEW OF THE PRODUCT DRAWING WAS CONDUCTED DURING THIS EVALUATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MATRIXMANDIBLE COMBINATION BENDER BROKE DURING SURGERY. ON (B)(6) 2016 A PATIENT UNDERWENT AN INITIAL OPEN REDUCTION INTERNAL FIXATION OF A MANDIBULAR FRACTURE. THE SURGEON USED A COMBINATION BENDER OUT OF A MATRIXMANDIBLE SET TO BEND A PLATE, AND THE BENDER BROKE. THE CASE WENT ON WITHOUT INTERRUPTION. THERE WAS NO SURGICAL DELAY. THE PATIENT DID NOT SUFFER ANY ILL EFFECTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339933 MATRIXMANDIBLE COMBINATION BENDER PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN T934907

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR