BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE

    MDR report key: 5732968 · Received June 17, 2016

    Report

    Report Number
    3000270450-2016-10142
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Date of Event
    May 31, 2016
    Report Date
    May 31, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. ARTICLE WAS STERILIZED BY SUPPLIER: (B)(4), MANUFACTURING DATE: OCTOBER 19, 2015, EXPIRY DATE: OCTOBER 1, 2025. ARTICLE 04.210.124 WAS MANUFACTURED IN THE US WITH LOT NUMBER 9812030. MANUFACTURING LOCATION: (B)(4). PACKAGED BY: (B)(4), MANUFACTURING DATE: SEPTEMBER 23, 2015. PART #: 04.210.124, LOT#: 9812030 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM. NO NCRS 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. 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

    PRODUCT INVESTIGATION SUMMARY: ONE (1) 2.4MM TI VA-LOCKING SCREW (PART: 04.210.124S / LOT: 9691431) WAS RECEIVED FOR EVALUATION. THE COMPLAINT CONDITION IS CONFIRMED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE LOCKING SCREW (2.4MM DIAMETER) IS AVAILABLE IN THE 2.4MM VA LCP DISTAL RADIUS SYSTEM AND THE 2.4MM/2.7MM VA LCP FOREFOOT/MIDFOOT SYSTEM. THE VA LCP DISTAL RADIUS SYSTEM OFFERS PLATES WHICH CONTAIN VA-LCP HOLES IN THE HEAD OF THE PLATE IN ORDER TO BETTER SUPPORT THE ARTICULAR SURFACE AND REDUCE THE NEED FOR BONE GRAFT. THE 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 RETURNED SCREW WAS EXAMINED UNDER MAGNIFICATION AND THE THREADS ALONG THE MIDDLE SHAFT OF THE SCREW APPEARED TO BE DEFORMED/PEELING APART, WHICH WOULD RESULT IN METAL DEBRIS. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. A REVIEW OF THE CURRENT DESIGN 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. 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE SUBJECT DEVICE WAS RECEIVED BY SYNTHES MANUFACTURER. THE SUBJECT DEVICE IS CURRENTLY IN THE EVALUATION PROCESS. 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) IS AS FOLLOWS; IT WAS REPORTED THAT DURING A SURGERY FOR FRACTURE OF THE RADIUS (DISTAL END) ON (B)(6) 2016, METAL DEBRIS WAS FOUND ON THE THREAD OF THE VA LOCKING SCREW THAT APPEARED LIKE STRING AND WAS FRAYED. THE SURGEON INITIALLY FOUND THREAD-LIKE METAL DEBRIS ON THE VA-TCP (VARIABLE ANGLE-TWO COLUMN PLATE) SURFACE WHEN TRYING TO INSERT THE SCREW INTO THE PLATE HOLE (THE SECOND HOLE FROM THE DISTAL ULNAR SIDE) AFTER PRE-DRILLING THE HOLE. AT THE TIME, THE SURGEON THOUGHT THE SCREW HAD SOME PROBLEM AND REMOVED IT. A NURSE FOUND THE SAME THREAD-LIKE METAL DEBRIS ON THE SCREW. THE METAL DEBRIS CAME FROM THE THREAD OF THE SCREW. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED. CONCOMITANT DEVICES REPORTED: VARIABLE ANGLE-TWO COLUMN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388201 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH 9691431

    Patients

    Seq Age Sex Outcome Treatment
    1