BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH CUTTER

    MDR report key: 4124165 · Received September 28, 2014

    Report

    Report Number
    9680938-2014-10066
    Event Type
    Malfunction
    Date Received
    September 28, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #KR320172 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING BETWEEN 47 HRC AND WAS FOUND TO BE GOOD. NO NCRS WERE GENERATED DURING PRODUCTION. 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: PRODUCT INVESTIGATION SUMMARY WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE MESH CUTTERS WERE RECEIVED LARGELY INTACT SAVE FOR A 2.5MM DISTAL TIP FROM 1 CUTTING BLADE BROKEN OFF AND MISSING. THE BROKEN TIP APPARENTLY OCCURRED FROM ROUGH HANDLING FROM EITHER DROPPING OR HEAVIER INSTRUMENTS DROPPED ON THE DEVICE SNAPPING THE TIP OFF. THE METHOD OF USE DURING CLEANING AND HANDLING HAS LED TO THIS COMPLAINT. THE DEVICE WAS MANUFACTURED 1/2007 AND IS OVER 7 YEARS OLD ((B)(4) DHR REVIEW). THE CUTTING BLADES WERE MEASURED (CA99) AND THE STRAIGHTNESS AND DIMENSIONAL RELATIONSHIPS EVALUATED, 2.5MM TIP IS MISSING FROM THE SERRATED BLADE AND THE SAME IS BENT INWARD AN ADDITIONAL 3-5 DEG. (B)(4) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED VINTAGE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. THE BROKEN OFF TIP AND BENT BLADE HAVE LIKELY BEEN SUBJECTED BY SOME FORM OF BLUNT FORCE IMPACT BEYOND WHAT THE DEVICE IS DESIGNED FOR. DELICATE SUPER HARD CARBIDE INSERTED CUTTING BLADES SUCH AS THESE MUST BE HANDLED WITH GREAT CARE OR SUCH BREAKAGE CAN OCCUR. THE BROKEN OFF TIP AND BENT BLADE HAVE LIKELY BEEN SUBJECTED BY SOME FORM OF BLUNT FORCE IMPACT BEYOND WHAT THE DEVICE IS DESIGNED FOR. IMPACT TO THE BLADE OF THE DEVICE HAS RESULTED IN THIS CONFIRMED COMPLAINT AND IS NOT THE RESULT OF A DESIGN DEFICIENCY. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MESH CUTTER TIP BROKE. IT WAS REPORTED THAT THE PRODUCT MANAGER CONFIRMS ON SIGNED QSF-048 THAT THE ISSUE WAS NOTICED DURING CLEANING, AND DID NOT BREAK DURING A CASE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604053 MESH CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ SYNTHES TUTTLINGEN 5442521

    Patients

    Seq Age Sex Outcome Treatment
    1