BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT ¿1.1 L56/39 F/CORE HOLE

    MDR report key: 6257797 · Received January 17, 2017

    Report

    Report Number
    3000270450-2017-10013
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: PRODUCT WAS NOT RETURNED AND AN INVESTIGATION COULD NOT BE PERFORMED WITHOUT MATERIAL. COMPLAINT CONFIRMED AS ON X-RAYS THERE IT IS CLEARLY VISIBLE THE BROKEN OFF DRILL BIT LIKE REPORTED. ROOT CAUSE COULD NOT BE DEFINED DUE THE MISSING MATERIAL. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND AS NO MATERIAL WAS RETURNED FOR INVESTIGATION. 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

    PATIENT ID, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.130.202S, LOT# L113564. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 14, 2016, EXPIRY DATE: AUG 01, 2026. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    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, THERE WAS A SURGERY TO TREAT A FRACTURE OF THE METACARPAL OF THUMB. THE SURGEON APPLIED A PHALANGE BASE VARIABLE ANGLE LOCKING PLATE FROM VARIABLE ANGLE LOCKING HAND SYSTEM FOR THE SURGERY. THE SURGEON USED A DRILL BIT WHICH WAS OPENED AND PREVIOUSLY USED DURING SURGERY ON (B)(6) 2016 AND THEREFORE NON-STERILE. HOWEVER, ITS TIP BROKE OFF AND LEFT INSIDE THE PATIENT¿S BODY. THE PATIENT WAS REPORTED AS STABLE. THERE WAS A PROLONGATION OF SURGERY, BUT THE DURATION IS UNKNOWN. REPORTED CONCOMITANT DEVICES: VA-LOCKING PLATE (QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40940 DRILL BIT ¿1.1 L56/39 F/CORE HOLE BIT, DRILL HTW SYNTHES SELZACH L113564

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ONE (1) UNKNOWN VA LOCKING PLATE