BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5412471 · Received February 5, 2016

    Report

    Report Number
    2520274-2016-10776
    Event Type
    Injury
    Date Received
    February 5, 2016
    Date of Event
    April 14, 2015
    Report Date
    January 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN 2.7MM (CORNER SCREWS), UNKNOWN QUANTITY / UNKNOWN LOT NUMBER. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: MELAMED, E., ET AL, (2015) "COMPLEX PROXIMAL ULNA FRACTURES: OUTCOMES OF SURGICAL TREATMENT" EUR J. ORTHOP SURG TRAUMATOL, 25:PP.851-858. PATIENTS HAD BEEN TREATED FOR PROXIMAL ULNA FRACTURES BY TWO SURGEONS BETWEEN 2004 AND 2011. ALL DATA WAS COLLECTED RETROSPECTIVELY. THE STUDY INCLUDED 38 PATIENTS WITH EITHER AN ISOLATED OLECRANON FRACTURE OR COMBINED INJURIES, ALL TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION OF THE OLECRANON. THERE WERE 27 MEN AND 11 WOMEN WITH AN AVERAGE AGE OF 49 YEARS. CHARTS, OPERATIVE REPORTS, RADIOGRAPHS, AND CT SCANS WERE ASSESSD. A TOTAL OF 49 ELBOW FRACTURES AND FRACTURE-DISLOCATIONS INVOLVING THE PROXIMAL ASPECT OF THE ULNA HAD BEEN TREATED SURGICALLY. ELEVEN PATIENTS WERE LOST TO FOLLOW-UP. THE REMAINING 38 ELBOWS FORMED THE BASIS OF THIS STUDY. THE PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO THE VARIANTS OF PROXIMAL ULNA FRACTURE: GROUP 1-OLECRANON (25 PATIENTS); GROUP 2-OLECRANON & CORONOID (5 PATIENTS); GROUP 3-OLECRANON & CORONOID & RADIAL HEAD (8 PATIENTS). THE PURPOSE OF THE PRESENT STUDY WAS TO EVALUATE THE MID-TERM FUNCTIONAL RECOVERY AND SURGICAL OUTCOME OF\ CONTOURED PLATING FOR COMMINUTED FRACTURES OF THE PROXIMAL ULNA WITH AND WITHOUT ASSOCIATED INJURIES. THE PLATES USED WERE RECONSTRUCTION PLATES (N = 4), 3.5-MM DYNAMIC COMPRESSION PLATES (N = 3), AND PROXIMAL ULNASPECIFIC PLATES (N = 31) (DEPUY-SYNTHES, (B)(4), OR ANOTHER MANUFACTURER'S PLATES. THIRD TUBULAR PLATES WERE USED FOR SUPPLEMENTAL FIXATION IN THREE CASES. OLECRANON-SPECIFIC LOCKING PLATES WERE UTILIZED IN 21 CASES (55 %) AND STANDARD NON-LOCKING PLATES IN 17 CASES (45 %). RADIAL HEAD FRACTURES (GROUP 3) WERE EITHER TREATED WITH METALLIC RADIAL HEAD ARTHROPLASTY IN SIX CASES (ANOTHER MANUFACTURER) OR FIXED WITH PLATES AND SCREWS IN TWO CASES. THREE PATIENTS HAD AN INTRACRANIAL INJURY. TWO PATIENTS HAD A SPINE INJURY. NINE PATIENTS HAD LOWER EXTREMITY FRACTURES. CORNER SCREWS (THE PROXIMAL-MOST SCREWS IN THE PROXIMAL FRAGMENT SCREW CLUSTER) WERE UTILIZED IN 19 CASES (50 %) AND WERE ALL WELL SEATED WITHIN THE PLATE. SCREW PROMINENCE DEFINED AS DISPLACEMENT OF THE SCREW HEAD FROM THE PLATE SURFACE AT LEAST ONE SCREW DIAMETER WAS EVIDENT IN 16 CASES (42 %). FAILURE OF FIXATION SECONDARY TO THE USE OF A SMALL 2.7MM SCREW USED AS A "HOME RUN SCREW" INSTEAD OF A 3.5MM SCREW. COMPLICATIONS OCCURRED IN 11 PATIENTS. HETEROTOPIC OSSIFICATION OCCURRED IN 10, REQUIRING SURGICAL EXCISION IN FOUR CASES DUE TO RESTRICTED MOTION. THREE PATIENTS PRESENTED WITH ULNAR NEUROPATHY, WHICH RESOLVED WITHIN THE FIRST 2 MONTHS. RESIDUAL SUBLUXATION WAS PRESENT IN ONE PATIENT, WHICH WAS SUBSEQUENTLY TREATED WITH BY REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) AND RADIAL HEAD ARTHROPLASTY. POST-SURGICALLY, REDUCTION WAS MAINTAINED AND THE FRACTURES ACHIEVED UNION IN ALL CASES. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 2.7MM SCREWS (CORNER SCREWS). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71650 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention