BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TROCAR

    MDR report key: 6215704 · Received December 30, 2016

    Report

    Report Number
    2520274-2016-15812
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 6, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 357.098, LOT # 1083358: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 16.FEB.2001: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION: REPORTED PROBLEM COULD NOT BE REPRODUCED. FULLY ASSEMBLED DEVICES DID MEET THE NAIL AS INTENDED. FUNCTIONAL TEST WAS PASSED SUCCESSFULLY WITH NO DEVIATION. VISUAL INSPECTION SHOWS NO DAMAGES. EVEN THIS DEVICE IS RATHER OLD AND OFTEN USED FUNCTIONAL TEST WAS PASSED SUCCESSFULLY, COULD BE ATTACHED TO THE COMPLETE SYSTEM WITHOUT ANY PROBLEMS. THE REPORTED PROBLEM COULD NOT BE REPRODUCED DURING INVESTIGATION. EVEN SOME OF THE AFFECTED PARTS ARE RATHER OLD AND OFTEN USED, ALL ARE IN FULL FUNCTIONALITY AND NO PRODUCT FAULT COULD BE IDENTIFIED. THEREFORE WE ARE NOT ABLE TO IDENTIFY ANY ROOT CAUSE FOR THE REPORTED PROBLEM. 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

    (B)(4). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY FOR THE FEMORAL DIAPHYSEAL FRACTURE. DURING THE SURGERY, THE SURGEON REAMED THE MEDULLARY CAVITY 1.5MM OVER THE REQUIRED DIAMETER. NEXT, HE TESTED SIDE STOPPAGE WITH A LONG NAIL IN A DRIED CONDITION AND SUCCEEDED IN THE TEST. THEN, HE INSERTED THE NAIL. BY SETTING THE STANDARD LOCKING MODE, HE STARTED THE SIDE STOPPAGE WITH LOCKING SCREWS ON THE DISTAL LOCATION. BY USING A BATTERY HANDPIECE HE TRIED ANOTHER SIDE STOPPAGE WITH A 4.9MM SCREW ON THE PROXIMAL LOCATION. BECAUSE HE WANTED TO EXTEND THE PATIENT¿S KNEE, THE SURGEON SET ASIDE AN AIMING ARM. NEXT, HE INSERTED AN END CAP. FINALLY, HE RE-STARTED THE SIDE STOPPAGE. DURING THE FINAL CHECK WITH IMAGES, THE SURGEON FOUND THAT THE 6.0MM SCREW ON THE MOST DISTAL LOCATION HAD NOT BEEN PROPERLY INSERTED INTO THE SIDE-STOPPAGE HOLE OF THE NAIL. AS A MATTER OF FACT, THE SCREW WAS INSERTED CLOSE TO THE FOREFRONT OF THE NAIL. THEREFORE THERE IS A POSSIBILITY TO REMAIN THE SCAR. THEN HE REMOVED THE SCREW. WITHOUT USING THE AIMING ARM, HE DRILLED MANUALLY AND TOOK MEASUREMENTS AGAIN. HE USED A 7.0MM SCREW AND FINISHED THE INSERTION. PATIENT HAS STRONG BONE QUALITY. THE REST OF THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS A SURGICAL PROLONGATION OF 10 MINUTES REPORTED. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. CONCOMITANT DEVICES: NAIL - 10MM IN DIAMETER; 30MM LONG. (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) 6.0MM TI LOCKING SCREW 65MM- F/DISTAL FEMORAL NAILS-STERILE (PART# 450.865S, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TROCAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865578 5.0MM TROCAR GUIDE FZX SYNTHES HAGENDORF 1083358

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR ONE (1) UNKNOWN NAIL| PART# 450.865S, LOT# UNKNOWN, QUANTITY 1