BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLCHUCK KEYLESS F/TRS CLAM RANGE - Ø6

    MDR report key: 3072947 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01861
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DRILL CHUCKS IN QUESTION WERE FORWARDED TO THE RESPONSIBLE PRODUCT MANAGER. HE DID PERFORM A FUNCTION TEST AND ALL DEVICES WERE FUNCTIONAL, ALTHOUGH THIS DRILL CHUCK WITH THE SERIAL NUMBERS (B)(4) WERE BADLY DAMAGED; OBVIOUSLY WITH ANY TOOL THAT WAS MANIPULATED AT THE DEVICE. IN THE INSTRUCTIONS FOR USE: IT IS ELEMENTARY THAT THE COUPLING SLEEVE IS PULLED BACK TO RELEASE AND LOOSEN THE DRILL CHUCK. NEXT TO THAT THE ATTACHMENT SHOULD NEVER BE CLOSED BY USING THE MACHINE. THIS CAN LEAD TO AN EXCESSIVE TIGHTENING OF THE INSERT AND FINALLY TO A BLOCKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNSPECIFIED PROCEDURE, FIVE TRAUMA RECON SYSTEM KEYLESS DRILL CHUCKS WERE BLOCKED. IT IS REPORTED THAT THERE WAS NO CONSEQUENCE TO THE PATIENT BECAUSE OF THIS EVENT. IT WAS REPORTED THAT THE DELAY IN SURGERY WAS LESS THAN 20 PERCENT, AND THAT THE EVENT DID NOT REQUIRE FURTHER TREATMENT. THERE WAS NO INCIDENT WITH THE PATIENT BECAUSE A DIFFERENT DEVICE WAS USED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174432 DRILLCHUCK KEYLESS F/TRS CLAM RANGE - Ø6 HWE SYNTHES GMBH SER.-NR. 2883

    Patients

    Seq Age Sex Outcome Treatment
    1