BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS

    MDR report key: 5050401 · Received September 2, 2015

    Report

    Report Number
    2520274-2015-15633
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 24, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4). - MANUFACTURING DATE: DECEMBER 10, 2014. 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 309.521, CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS, LOT NUMBER 9212979). THE SUBJECT DEVICE WAS RECEIVED AND VISUAL INSPECTION HAS SHOWN THAT HE BROKEN OFF TIP IS MISSING AND THE SURFACE DOES SHOW SOME MARKS OF USE. BASED ON THE COMPLAINT DESCRIPTION AND THAT THIS BROKEN OFF TIP WAS DETECTED BY A PRE-SURGICAL CHECK. IT IS POSSIBLE THAT THE DEVICE WAS SUBJECTED TO FORCE OVERLOAD OR MAY HAVE BEEN DROPPED ON THE FLOOR, RESULTING IN THE COMPLAINT CONDITION. THERE WAS NO INDICATION OF MANUFACTURING, MATERIAL OR DESIGN-RELATED ISSUES ASSOCIATED WITH THIS DEVICE. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON FOUND BREAKAGE OF THE REPORTED EXTRACTION SCREW IN PRE-SURGERY CHECK. AS THE SPARE DEVICE WAS PREPARED, THE SURGERY WAS CONDUCTED AS PLANNED WITH NO PROBLEM. NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581288 CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS EXTRACTOR HWB SYNTHES BETTLACH 9212979

    Patients

    Seq Age Sex Outcome Treatment
    1