BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT ¿1.1 L56/39 F/CORE HOLE

    MDR report key: 6575239 · Received May 18, 2017

    Report

    Report Number
    3000270450-2017-10169
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 19, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER L113564. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE:14.SEP.2016. EXPIRATION DATE: 01.AUG.2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OR STERILIZATION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OR STERILIZATION OF THE SUBJECT DEVICE. 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 FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN SURGERY FOR THE SECOND AND THIRD METACARPAL FRACTURE. WHILE DRILLING, THE DRILL BIT IN QUESTION ATTACHED TO THE POWER TOOL DID NOT GO FORWARD. WHEN EXTRA FORCE WAS APPLIED TO THE DRILL BIT, THE SURGEON FELT SOMETHING WRONG. THE X-RAY WAS TAKEN DURING THE SURGERY. IT WAS FOUND THAT THERE WAS A BROKEN TIP OF THE DRILL BIT IN QUESTION IN THE METACARPAL BONE ON THE X-RAY. THE BROKEN PIECE OF THE DRILL BIT IN QUESTION WAS LEFT IN THE METACARPAL BONE BY SURGEON¿S MEDICAL JUDGEMENT SINCE THE BROKEN PIECE WAS EMBEDDED COMPLETELY IN THE BONE ALTHOUGH THE SURGEON TRIED TO REMOVE THE BROKEN PIECE OF THE DRILL BIT. ACCORDING TO THE SURGEON¿S OPINION, THE SURGEON MIGHT BE DRILLING THE BONE BY APPLYING EXTRA FORCE, AND THE BONE QUALITY OF THE PATIENT MIGHT HAVE BEEN HARD. THE SURGERY WAS EXTENDED FOR FIVE MINUTES BUT WAS SUCCESSFULLY COMPLETED WITH NO OTHER MEDICAL INTERVENTION REQUIRED. CONCOMITANT DEVICES: 1X UNK POWER TOOL (VA-HAND). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356251 DRILL BIT ¿1.1 L56/39 F/CORE HOLE BIT, DRILL HTW SYNTHES SELZACH L113564

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention QTY 1 UNKNOWN POWER TOOL