BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5233924 · Received November 18, 2015

    Report

    Report Number
    2520274-2015-17397
    Event Type
    Injury
    Date Received
    November 18, 2015
    Report Date
    November 3, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. POTENTIAL PART NUMBERS PROVIDED; IT IS UNKNOWN WHICH ARE THE COMPLAINED SCREWS. 02.211.032 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM, K100776; 02.211.034 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 34MM, K100776; 2 - 02.211.038 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 38MM, K100776; 2 - 02.211.040 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM, K100776; 2- 204.814 3.5MM CORTEX SCREW SELF-TAPPING 14MM, K131186; 4 - 204.816 3.5MM CORTEX SCREW SELF-TAPPING 16MM, K131186; 204.832 3.5MM CORTEX SCREW SELF-TAPPING 32MM, K131186. ADDITIONAL PRODUCT CODE: HWC. UNKNOWN; REPORTED AS APPROXIMATELY 6 WEEKS BEFORE EXPLANT ON (B)(6) 2015. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THERE WAS A REVISION OF RIGHT DISTAL TIBIA DE-ROTATION OSTEOTOMY FOR A NON-UNION AND BROKEN SCREWS IN THE PLATE. VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL MEDIAL TIBIA PLATE WAS INSERTED APPROXIMATELY SIX (6) WEEKS AGO FOR A DE-ROTATIONAL OSTEOTOMY OF RIGHT DISTAL TIBIA. MULTIPLE 2.7 VA-LOCKING AND 3.5 LOCKING SCREWS THAT WERE USED TO FIX THE PLATE TO THE BONE HAD BROKEN AND OSTEOTOMY SITE HAD NOT UNITED. THEY WERE UNABLE TO REMOVE FOUR (4) OF THE 2.7 VA LOCKING BROKEN SCREW SHAFTS FROM THE DISTAL TIBIA. THE SURGEON COMMENTED HE SUSPECTED THE PATIENT HAD A LOW GRADE INFECTION (THIS WAS NOT CONFIRMED) AND THAT THEY DID NOT FOLLOW POST-OPERATIVE PROTOCOL (I.E. INCREASED WEIGHT BEARING / ACTIVITY LEVELS TOO QUICKLY) WHICH COULD HAVE CAUSED THE SCREWS TO BREAK. THE PATIENT WAS REVISED TO LCP DISTAL MEDIAL TIBIA PLATE ON (B)(6) 2015. THE FOUR (4) 2.7 VA LOCKING SCREW SHAFTS THAT COULD NOT BE REMOVED WERE BURIED UNDER THE CORTEX, WERE WELL FIXED AND NOT PROTRUDING. THE SURGEON IS NOT CONCERNED ABOUT THIS BEING A PROBLEM FOR THE PATIENT. THE PATIENT WAS NON-WEIGHT-BEARING POST OPERATIVELY. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764340 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention