BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER

    MDR report key: 4395931 · Received January 8, 2015

    Report

    Report Number
    1000562954-2015-10002
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 12, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK092556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFYING INFORMATION IS NOT AVAILABLE FOR REPORTING. IT IS UNKNOWN IF THIS SPECIFIC PART BELONGS TO LOT 8942148 OR LOT 9140075. IMPLANT AND EXPLANT DATES: UNKNOWN. PER FACILITY, THE COMPLAINANT PART WILL NOT BE RETURNED TO THE MANUFACTURER FOR REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: NO NON-CONFORMANCE REPORTS 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. LOT 8942148 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: 29.APR.2014 EXPIRY DATE: 01.APR.2024 LOT 9140075 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: 18.SEP.2014 EXPIRY DATE: 01.SEP.2024 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOR DISTAL RADIUS FRACTURE A VARIABLE ANGLE LOCKING COMPRESSION PLATE WAS USED. TO THE DISTAL PART OF THE PLATE IN QUESTION, A DEDICATED GUIDING BLOCK WAS MOUNTED AND SCREWS WERE INSERTED FROM THE ULNA SIDE AFTER DRILLING WITH A DEDICATED SLEEVE. IN THE LAST HOLE, THE SCREW HEAD PENETRATED THE PLATE. AFTER EXTRACTING THAT SCREW WITH AN INCISION IN THE DISTAL PART, THE SURGEON CONFIRMED THE GUIDING BLOCK WAS TIGHTLY ATTACHED SINCE THE SURGEON SUSPECTED THAT THE SCREW HAD BEEN INSERTED OUTSIDE THE PLATE BECAUSE OF LOOSE ATTACHMENT OF THE GUIDING BLOCK. THEN THE SURGEON RETRIED TO INSERT THE SCREW; HOWEVER, IT PENETRATED THE PLATE AGAIN. EVENTUALLY THE SURGEON GAVE UP WITH THIS HOLE AND FIXED WITH THE PROXIMAL HOLE (THE SECOND ROW) USING ANOTHER SCREW. A TWENTY MINUTE SURGICAL DELAY WAS REPORTED. DAMAGE TO THE PATIENT¿S CANCELLOUS BONE WAS REPORTED. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15385 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention