BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5426830 · Received February 10, 2016

    Report

    Report Number
    2520274-2016-10954
    Event Type
    Injury
    Date Received
    February 10, 2016
    Report Date
    January 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF POST-OPERATIVE PAIN AND SCREW MOVEMENT IS UNKNOWN. THIS REPORT IS FOR TWELVE (12) UNKNOWN SCREWS. THE TWELVE SCREWS (PART NUMBERS UNKNOWN) INCLUDE: TWO (2) 2.7MM METAPHYSEAL SCREWS, THREE (3) 2.7MM VARIABLE ANGLE LOCKING SCREWS, SIX (6) 3.5MM CORTICAL SCREWS, AND ONE (1) 2.5MM LOCKING SCREWS. WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE APPROXIMATELY TWO (2) TO THREE (3) MONTHS AGO. THE COMPLAINANT PARTS ARE EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAVE YET TO BE RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. TWELVE SCREWS WERE RECEIVED BY THE MANUFACTURER FOR THIS COMPLAINT; HOWEVER, IT IS UNKNOWN WHICH OR HOW MANY OF THESE SCREWS BACKED OUT. LOT NUMBERS WERE NOT AVAILABLE FOR THE RETURNED SCREWS. THE RECEIVED SCREWS ARE AS FOLLOWS: QTY 1: PART NUMBER 02.211.024, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM, 510(K) K100776, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. QTY 1: PART NUMBER 02.211.028, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM, 510(K) K100776, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. QTY 1: PART NUMBER 02.211.038, 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 38MM, 510(K) K100776, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. QTY 1: PART NUMBER 02.118.530, 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/30MM, 510(K) K120854, DEVICE PRODUCT CODES HWC & HRS, COMMON NAMES SCREW, FIXATION, BONE AND PLATE, FIXATION, BONE. QTY 1: PART NUMBER 02.118.538, 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/38MM, 510(K) K120854, DEVICE PRODUCT CODES HWC & HRS, COMMON NAMES SCREW, FIXATION, BONE AND PLATE, FIXATION, BONE. QTY 1: PART NUMBER 212.109, 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM, 510(K) K072095, DEVICE PRODUCT CODE JDS, COMMON NAME NAIL, FIXATION, BONE. QTY 3: PART NUMBER 204.822, 3.5MM CORTEX SCREW SELF-TAPPING 22MM, 510(K) K131186, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. QTY 1: PART NUMBER 204.820, 3.5MM CORTEX SCREW SELF-TAPPING 20MM, 510(K) K112583, PRODUCT CODE HWC, COMMON NAME SCREW, FIXATION, BONE. QTY 1: PART NUMBER 204.826, 3.5MM CORTEX SCREW SELF-TAPPING 26MM, 510(K) K131186, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. QTY 1: PART NUMBER 204.824, 3.5MM CORTEX SCREW SELF-TAPPING 24MM, 510(K) K131186, DEVICE PRODUCT CODES HRS & HWC, COMMON NAMES PLATE, FIXATION, BONE AND SCREW, FIXATION, BONE. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. THE SCREWS WERE RECEIVED WITH DAMAGE TO THE THREADS CONSISTENT WITH IMPLANTATION AND REMOVAL. THE RETURNED SCREWS ARE PART OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP ELBOW SYSTEM PER THE TECHNIQUE GUIDE AND ARE RECOMMENDED FOR REPAIR OF THE DISTAL HUMERUS FROM FRACTURES, OSTEOTOMIES, MALUNIONS, AND NON-UNIONS. THE PRODUCT DRAWINGS WERE REVIEWED AS PART OF THE INVESTIGATION. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE CAUSE OF THE IMPLANT LOOSENING AND SUBSEQUENT PATIENT PAIN IS UNKNOWN. SINCE NO X-RAY IMAGES WERE RECEIVED, THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. 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 ONE (1) VARIABLE ANGLE - LOCKING COMPRESSION PLATE (VA-LCP) AND TWELVE (12) UNKNOWN SCREWS WERE EXPLANTED ON (B)(6) 2016 DUE TO SCREW MOVEMENT (BACK OUT) AND COMPLAINTS OF PAIN. THE ORIGINAL PROCEDURE OCCURRED TWO (2) OR THREE (3) MONTHS PRIOR IN ORDER TO TREAT A DISTAL HUMERUS FRACTURE. THE PLATE AND SCREWS WERE REMOVED FULLY INTACT AND THE PATIENT WAS SUCCESSFULLY REVISED TO A DOUBLE PLATED SYSTEM WITH ONE (1) MEDIAL PLATE AND ONE (1) LATERAL PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. THIS REPORT IS FOR TWELVE (12) UNKNOWN SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84506 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention