BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4371143 · Received December 30, 2014

    Report

    Report Number
    2520274-2014-15645
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    November 14, 2014
    Report Date
    December 2, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 2.4 MM LOCKING SCREW. PRODUCT NUMBER: PARTIAL NUMBER REPORTED AS 412.8XXS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PARTIAL PART NUMBER WAS REPORTED AS 412.8XXS. THIS NUMBER CORRESPONDS 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS AND 510(K) K103243. A MANUFACTURING EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS RECEIVED WITH THE SCREW HEAD BROKEN OFF AS COMPLAINED. BASED ON THE RECEIVED INFORMATION THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE BREAKAGE MAY HAVE BEEN CAUSED DUE TO A MECHANICAL OVERLOADING SITUATION. AS THE PART AND LOT NUMBER ARE UNKNOWN, A DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING RECORDS OR A COMPLAINT HISTORY CANNOT BE PERFORMED FOR THE SUBJECT DEVICE. THE COMPLAINT CONDITION IS CONFIRMED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.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 DURING THE PLATE REMOVAL OPERATION AFTER THE DISTAL RADIUS FRACTURE, THE SCREW HEAD GOT BROKEN AND THE SCREW SHAFT WAS LEFT IN THE PATIENT'S BONE. NO SURGICAL DELAY WAS REPORTED DUE TO THIS EVENT. THIS REPORT IS FOR AN UNKNOWN 2.4 MM LOCKING SCREW. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857162 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR