BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5773239 · Received July 6, 2016

    Report

    Report Number
    2520274-2016-13378
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 22, 2016
    Report Date
    June 22, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. A PRODUCT INVESTIGATION WAS COMPLETE: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED: ONE 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM (PART NUMBER: 310.509, LOT NUMBER: U240157, MANUFACTURE DATE: FEBRUARY 22, 2016) AND ONE UNKNOWN - SCREW LOCKING: BASED ON COMPLAINT DESCRIPTION, DESIGN/COLOR OF RETURNED SCREW HEAD; THE SCREW MOST LIKELY BELONGS TO 2.4MM VARIABLE ANGLE (VA) LOCKING SCREW, SELF-TAPPING WITH STARDRIVE RECESSES (PART NUMBERS: 02.210.1XX AND 04.210.1XX). THE COMPLAINT CONDITION IS UNCONFIRMED FOR DRILL BIT. THE COMPLAINT WAS UNABLE TO BE REPLICATED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WITH THE RETURNED INSTRUMENT. THE COMPLAINT CONDITION IS CONFIRMED FOR THE SCREW. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT, WHERE APPLICABLE, WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. BOTH RETURNED COMPLAINT DEVICES ARE MENTIONED IN SEVERAL TECHNIQUE GUIDES INCLUDING: 2.4MM VA LCP VOLAR EXTRA-ARTICULAR DISTAL RADIUS SYSTEM, THE 2.4MM VA LCP DISTAL RADIUS SYSTEM, THE 2.4MM/2.7MM VA LCP FOREFOOT/MIDFOOT SYSTEM, AND THE MODULAR MINI FRAGMENT LCP SYSTEM. THE DRILL BIT IS USED TO DRILL A PILOT HOLE TO INSERT THE 2.4MM SCREW ONTO A PLATE. THE VA SCREWS CAN BE ANGLED ANYWHERE WITHIN A 30 DEGREE CONE OF ANGULATION AND ARE RETAINED BY FOUR COLUMNS OF THREADS WHICH PROVIDE FOUR POINTS OF CONTACT BETWEEN THE PLATE AND SCREW FORMING A FIXED-ANGLE CONSTRUCT. THE DRILL BIT WAS VISUALLY INSPECTED UNDER A 5X LOUPE AND NO DAMAGE WAS NOTED. THE INSTRUMENT IS IN FAIR CONDITION AND THE DRILL BIT TIP APPEARS TO BE IN FUNCTIONAL CONDITION. A DHR REVIEW WAS PERFORMED FOR THIS PART. 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. ONLY THE SCREW HEAD WAS RETURNED AS THE SHAFT REMAINS IN THE PATIENT; THE SECTION WAS EXAMINED UNDER A %X LOUPE AND IT CAN BE SEEN THAT IT HAS BEEN SHEARED OFF FROM THE REST OF THE SCREW. SINCE THE SCREW SHAFT WAS NOT RETURNED IT IS IMPOSSIBLE TO DETERMINE EXACT PART NUMBER OF SCREW. THIS COMPLAINT IS CONFIRMED. A REVIEW OF THE CURRENT DESIGN DRAWING AND AVAILABLE HISTORY FOR THE TOP LEVEL DRAWING FOR THE SCREWDRIVER WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE MAY BE CONSISTENT WITH ATTEMPTED INSERTION OF THE SCREW UNDER TOO MUCH POWER/USE OF COMPETITOR DRILL/PATIENT¿S HARD BONE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN 2.4MM VA LOCKING BUTTRESS SCREW/UNKNOWN PART/UNKNOWN LOT. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 REPORTED THAT ON (B)(6) 2016, DURING A PROCEDURE FOR A BROKEN DISTAL RADIUS LEFT WRIST, THE SURGEON WAS INSERTING THE 2.4MM VARIABLE ANGLE (VA) LOCKING BUTTRESS SCREW IN AN UNKNOWN SCREW LOCATION ON THE PLATE WHEN THE SCREW HEAD SNAPPED OFF. THE SURGEON WAS USING A COMPETITOR'S POWER DRILL, WITH A SYNTHES 1.8MM DRILL BIT. THE DRILL BIT STARTED TO WOBBLE AND THE SCREW BROKE RIGHT BELOW THE HEAD. SURGEON STATED THE PATIENT HAD VERY HARD BONE. SURGEON CHOSE TO LEAVE THE DISTAL PORTION OF THE SCREW IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL TIME OR HARM TO THE PATIENT. PATIENT IS REPORTED IN STABLE CONDITION. THE PATIENT INITIALLY PRESENTED WITH WRIST TRAUMA FRACTURE. CAUSE OF THE FRACTURE IS UNKNOWN. PATIENT WAS IMPLANTED WITH A 2.4MM/ 9 HOLE/ 170MM LOCKING COMPRESSION PLATE (LCP) STRAIGHT WRIST PLATE AND UNKNOWN QUANTITY OF VARIABLE ANGLE LOCKING SCREWS. THIS REPORT IS FOR AN UNKNOWN 2.4MM VARIABLE ANGLE (VA) LOCKING BUTTRESS SCREW. CONCOMITANT DEVICES REPORTED: 2.4MM LCP(TM) STRAIGHT WRIST PLATE 170MM (PART # SD242.003, LOT # UNKNOWN, QUANTITY # (B)(4)). THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427538 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention