BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM

    MDR report key: 6855597 · Received September 11, 2017

    Report

    Report Number
    3000270450-2017-10319
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 18, 2017
    Report Date
    August 18, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRS. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 06.FEB.2017 EXPIRY DATE: 01.JAN.2027. 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. NON-STERILE 04.211.032 / (B)(4) WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 10-NOV-2016. PART #: 04.211.032, LOT#: H223584 (NON-STERILE) ¿ 2.7MM TI VA LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM. QTY: 240. COMPONENTS REVIEWED, PART NO: 04.211.032.999, 2.8MM TI SCREW BLANK 32MM. LOT: 9818562. INSPECTION SHEET FOR MILL SHAFT THREADS, TURN/ THREAD HEAD, FLUTE FINAL INSPECTION (B)(4) REV: H MEET SPECIFICATION. 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGERY FOR THE DISTAL HUMERUS TUMOR TOOK PLACE ON (B)(6) 2017. THE SURGEON INSERTED THE VARIABLE ANGLE LOCKING SCREW WITH THE ANTERIOR CORTICAL BONE SINCE THE PLATE HAD BEEN TOUCHED TO THE PLATE ANTERIORLY. THE SURGEON HAD A DIFFICULTY IN INSERTING THE SCREW BECAUSE AN EXTRA FORCE WAS APPLIED TO THE SCREW IN QUESTION AGAINST THE CORTICAL BONE. WHEN THE SURGEON ROTATED THE HUMERUS EXTERNALLY DURING THE DIRECTION CONFIRMATION UNDER X-RAY, ABNORMAL SOUND WAS HEARD. AFTER THAT, SINCE THE SCREW IN QUESTION WAS PROTRUDED ANTERIORLY FROM THE PLATE, THE SURGEON DECIDED TO REPLACE IT WITH ANOTHER SCREW. WHEN THE SURGEON TURNED THE SCREW IN QUESTION COUNTER-CLOCKWISE MANUALLY BY USING A SCREW DRIVER, THE HEAD OF THE SCREW WAS BROKEN. THE SCREW PART WAS REMAINED IN THE BONE. SINCE THE PLATE WAS FIXED WITH THREE SCREWS AT DIFFERENT DISTAL HOLES, THE OPERATION WAS COMPLETED. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICES REPORTED: PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 3). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636461 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM SCREW,FIXATION,BONE HWC SYNTHES SELZACH L295218

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR