BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5871535 · Received August 12, 2016

    Report

    Report Number
    2520274-2016-14057
    Event Type
    Injury
    Date Received
    August 12, 2016
    Report Date
    July 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS (B)(6). PATIENT INITIALS ARE (B)(6). EXACT DATE OF SYMPTOM ONSET IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM LOW PROFILE CORTEX SCREW. OTHER): WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA# : UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT SCREWS WERE NOT PROVIDED. HOWEVER, BASED UPON THE REPORTED SYSTEM, THE LIKELY 510K IS K111230. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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

    THE INITIAL MEDWATCH IDENTIFIED ONE (1) 2.7MM VA LOCKING SCREW HAVING BEEN EXPLANTED; HOWEVER, THERE WERE A TOTAL OF THREE (3) 2.7MM VA LOCKING SCREWS REMOVED DURING THE REVISION. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2016 DUE TO REPORTS OF POST-OPERATIVE PAIN. THE PATIENT HAD ORIGINALLY SUSTAINED A DISTAL TIBIA/FIBULA FRACTURE THAT REQUIRED FIXATION. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. SOMETIME THEREAFTER, THE PATIENT BEGAN EXPERIENCING PAIN IN THE AREA OF IMPLANT. AS A RESULT, A REVISION WAS UNDERTAKEN TO REMOVE ALL OF THE ORIGINAL HARDWARE, WHICH INCLUDED: ONE (1) 2.7/3.5MM VARIABLE ANGLE - LOCKING COMPRESSION (VA-LCP) MEDIAL DISTAL TIBIA PLATE, ONE (1) 2.7MM VA LOCKING SCREW, ONE (1) 2.7MM METAPHYSEAL SCREW, ONE (1) 3.5MM LOW PROFILE CORTEX SCREW, AND THREE (3) 3.5MM VA LOCKING SCREWS. ALL HARDWARE WAS INTACT AT THE BEGINNING OF THE PROCEDURE; HOWEVER, TWO (2) SCREWS BROKE DURING EXPLANT. A TWENTY (20) TO THIRTY (30) MINUTE DELAY RESULTED, BUT THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. THIS REPORT WILL ADDRESS THE REASON FOR REVISION ONLY (PAIN). THE REPORTED INTRAOPERATIVE EVENT, AND RESULTING SURGICAL DELAY, WILL BE CAPTURED IN AND REPORTED UNDER LINKED (B)(4). THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM LOW PROFILE CORTEX SCREW. THIS REPORT IS 4 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    CORRECTION: THE EXPLANTED HARDWARE INCLUDED THREE (3) 2.7MM VA LOCKING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524970 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention