BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AWL

    MDR report key: 5079271 · Received September 15, 2015

    Report

    Report Number
    3003875359-2015-10394
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE INVESTIGATION SUMMARY ¿ THE INVESTIGATION HAS SHOWN THAT THE TIP OF THE AWL IS BROKEN OFF. IN ADDITION, THE REMAINING CUTTING EDGES ARE BADLY DAMAGED. THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JULY 2008 ACCORDING TO THE SPECIFICATIONS. THIS AWL IS MADE OF HARDENED STAINLESS STEEL. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. IN ADDITION THESE INSTRUMENTS ARE SUBJECTED TO A 100% CONTROL BEFORE THEY LEAVE THE MANUFACTURING FACILITY. BASED ON THESE FINDINGS AND CONSIDERING THE AGE OF THIS ARTICLE (SOLD IN AUGUST 2008 TO THE HOSPITAL) IT CAN BE CONCLUDED THAT THIS OCCURRENCE WAS CAUSED BY FATIGUE AND OVERLOAD. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 17JULY2008. 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. 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 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: DURING OPENING OF THE MEDULLARY CANAL WITH THE AWL FOR TITANIUM ELASTIC NAIL, THE TIP BROKE AND REMAINED IN THE PATIENT'S BONE. NO PROLONGATION IN SURGERY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: PER UPDATED REPORT RECEIVED ON OCTOBER 19, 2015, THE PROCEDURE WAS DELAYED BY AN UNKNOWN LENGTH OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608902 AWL AWL HWJ SYNTHES HAGENDORF 1940995

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention