BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 6122074 · Received November 22, 2016

    Report

    Report Number
    3000270450-2016-10277
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.4MM TI VARIABLE ANGLE (VA) LOCKING SCREW STARDRIVE 20MM-STERILE, PART NUMBER 04.210.120S, LOT NUMBER L083791). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE MICROSCOPIC INVESTIGATION OF THE COMPLAINED (VA) LOCKING SCREW Ø2.4 SELF-TAP L20 TAN SHOWS THAT THE THREADS ON THE LOCKING HEAD WERE DAMAGED DURING USE. THE FLANKS OF THE THREADS ARE ROUNDED AND WORN. THE ANODIZED ROSE RED COLOR WAS ABRADED IN ALL AFFECTED AREAS. THE CONDITION OF THE THREAD ON THE SCREW HEAD INDICATES THAT IT GOT DAMAGED BECAUSE OF CROSS-THREADING OR FORCIBLE USE DURING INSERTION. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND THERE WERE NO QUALITY ISSUES ASSOCIATED WITH THIS ARTICLE AND LOT NUMBER. BASED ON THE EVENT DESCRIPTION A DRIVER WITH A TORQUE LIMITATION ATTACHMENT WAS USED TO INSERT THE SCREW. HOWEVER THE VALID SURGICAL TECHNIQUE DESCRIBES THAT TO INSERT THE (VA) LOCKING SCREWS MANUALLY WITH THE SELF- RETAINING T8 STARDRIVE SCREWDRIVER SHAFT AND QUICK COUPLING HANDLE AND TIGHTEN JUST ENOUGH FOR THE SCREW HEAD TO BE FULLY SEATED IN THE (VA) LOCKING HOLE (1). BECAUSE OF THE EXISTING POST-MANUFACTURING DAMAGE AND THE UNKNOWN TECHNIQUE AND CONDITIONS DURING SCREW INSERTION THE COMPLAINT ROOT CAUSE IS INDETERMINATE. 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

    ADDITIONAL NARRATIVE: (B)(4). EVENT OCCURRED DURING THE PROCEDURE. DEVICE WAS NOT IMPLANTED OR EXPLANTED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 04.210.120S, LOT # L083791. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 05, 2016, EXPIRY DATE: JUL 01, 2026. ARTICLE WAS STERILIZED BY SUPPLIER (B)(4) WITH LOT NUMBER L083791. ARTICLE 04.210.120 WAS MANUFACTURED IN THE US WITH LOT NUMBER H031250. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUN 08, 2016. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT PROCEDURE FOR DISTAL RADIUS FRACTURE. THE SURGEON ADOPTED A VA-LCP (VARIABLE ANGLE LOCKING COMPRESSION PLATE). A VA LOCKING SCREW WAS USED FOR THE MOST DISTAL HOLE BY USING A DRIVER WITH A TORQUE LIMITATION ATTACHMENT. HOWEVER, THE SCREW DIDN'T LOCK SO THE SURGEON DIDN'T INSERT ANYTHING INTO THE HOLE. THERE WAS NO PROBLEM WITH THE OTHER HOLES. THERE WAS A SURGICAL PROLONGATION OF 10 MINUTES. INFORMATION ABOUT PATIENT AND SURGICAL OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICES: 2.4MM TI VA-LCP 2-COL DSTL RAD 2.4MM TI VA-LCP 2-COL DSTL RAD (PART # 04.111.541S, LOT # 9701215, QUANTITY 1). SCREW DRIVER SHAFT, T8 SHORT SELF-HOLD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). TORQUE LIMITING ATTACHMENT (PART # 511.776, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773499 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH L083791

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN SCREWDRIVER SHAFT| PART # 04.111.541S, LOT # 9701215, QUANTITY 1| PART # 511.776, LOT # UNKNOWN, QUANTITY 1