BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 5820552 · Received July 25, 2016

    Report

    Report Number
    2530088-2016-10203
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. (B)(6). SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE HANDLE OF THE SCREWDRIVER SPUN FREELY FROM THE SHAFT; THE REPAIR TECHNICIAN REPORTED THE SHAFT WAS DAMAGED/BROKEN OFF INSIDE THE HANDLE AT THE LOCKING PIN AND THAT THE HANDLE WAS WORN AND DISCOLORED. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED FOR FURTHER EVALUATION. THE EVALUATION WAS CONFIRMED. PRODUCT INVESTIGATION SUMMARY: ONE (1) LARGE HEXAGONAL SCREWDRIVER (PART: 314.27 / LOT: 5254186) WAS RECEIVED FOR EVALUATION WITH COMPLAINT CATEGORY ¿DOES NOT/WILL NOT FUNCTION: LOOSE." THIS COMPLAINT IS CONFIRMED AS THE RETURNED DEVICE WAS RECEIVED IN TWO (2) PIECES (THE SHAFT HAS SHEARED IN HALF AT THE LOCATION WHERE IT IS SECURED TO THE HANDLE WITH A DOWEL PIN). THE COMPLAINT CONDITION IS CONFIRMED, BUT NOT CONSISTENT WITH THE REPORTED CONDITION. THE FAILURE MODE OF BROKEN: INTRA-OPERATIVELY WILL BE SELECTED FOR THIS EVALUATION TO ACCOUNT FOR THE SHAFT COMPONENT BREAKING INTO TWO (2) PIECES INSIDE THE HANDLE. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE'S SHAFT IS ALREADY BROKEN. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, A DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE LARGE HEXAGONAL SCREWDRIVER IS A COMMON TRAUMA INSTRUMENT INCLUDED IN THE LARGE FRAGMENT SYSTEM AND USED ACROSS VARIOUS SYSTEMS FOR SCREW INSERTION AND REMOVAL. A REVIEW OF THE CURRENT DESIGN DRAWING FOR THE TOP LEVEL ASSEMBLY AND THE SCREWDRIVER SHAFT COMPONENT WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE MANUFACTURER IS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY EXCESSIVE TORSIONAL FORCE RESULTING IN THE SHAFT BREAKING. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. SERVICE HISTORY RECORD REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART: 314.27 / LOT: 5254186 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JUNE 7, 2006. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING SITE: (B)(6) - MANUFACTURING DATE: JUNE 7, 2006 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 THIS PRODUCT, OR ANY OF ITS SUBCOMPONENTS, 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.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO INSERT A 4.5MM CORTEX SCREW WITH A LARGE HEXAGONAL SCREWDRIVER. IT WAS NOTED THAT THE HANDLE OF THE SCREWDRIVER SPUN FREELY FROM THE SHAFT. ANOTHER DEVICE WAS READILY AVAILABLE FOR USE TO COMPLETE THE PROCEDURE. A FIVE (5) MINUTE SURGICAL DELAY WAS NOTED, BUT NO PATIENT HARM IDENTIFIED. THE INITIAL INVESTIGATION OF THE RETURNED DEVICE, WHICH WAS COMPLETED ON (B)(6) 2016, IDENTIFIED THAT THE DEVICE WAS IN FACT BROKEN. AS SUCH, THE REPORTABILITY DETERMINATION WAS UPDATED TO REFLECT THE RECEIVED CONDITION OF THE DEVICE. CONCOMITANT DEVICE(S) REPORTED: 4.5MM CORTEX SCREW (PART/LOT: UNKNOWN, QUANTITY: (B)(4)). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472073 LARGE HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES BRANDYWINE 5254186

    Patients

    Seq Age Sex Outcome Treatment
    1