BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5113729 · Received September 30, 2015

    Report

    Report Number
    2520274-2015-16338
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 14, 2015
    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. ROTH, JEFFREY J., ET AL. (2005). FIXATION OF HAND FRACTURES WITH BICORTICAL SCREWS. J HAND SURG 2005;30A:151-153. THIS REPORT IS FOR UNKNOWN SCREW, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4). 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: ROTH, JEFFREY J., ET AL. (2005). FIXATION OF HAND FRACTURES WITH BICORTICAL SCREWS. J HAND SURG 2005;30A:151-153. FROM FEBRUARY 1994 TO JULY 2002, 36 PATIENTS UNDERWENT BICORTICAL SCREW FIXATION FOR FRACTURES OF THE PHALANGES AND METACARPALS, WITH 26 MALE AND 10 FEMALE PATIENTS. AGES RANGED FROM 7 TO 55 YEARS WITH A MEAN OF 28 YEARS. THIRTY-SEVEN FRACTURES OF THE PHALANGES AND METACARPALS IN 36 PATIENTS HAD OPEN REDUCTION AND INTERNAL FIXATION. AFTER FRACTURE REDUCTION, COMPRESSION WAS APPLIED ACROSS THE FRACTURE SITE WITH A BONE-REDUCTION CLAMP. 1.1 - TO 2.4-MM SELF TAPPING TITANIUM SCREW (SYNTHES, (B)(4); LEIBINGER-STRYKER, (B)(4)) WERE INSERTED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO THE FOLLOWING COMPLICATIONS: ONE PATIENT, WHO HAD ORIGINALLY PRESENTED TO THE OFFICE 5 WEEKS AFTER INJURY, REQUIRED A SUBSEQUENT SURGERY. FOUR MONTHS AFTER OPEN REDUCTION AND INTERNAL FIXATION THE PATIENT REQUIRED TENOLYSIS AND CAPSULAR RELEASE FOR A PROXIMAL INTERPHALANGEAL EXTENSION CONTRACTURE. THE SCREWS WERE REMOVED FROM THE HEALED PHALANX OF THE CONDYLAR FRACTURE AT THE TIME OF THE TENOLYSIS. ANOTHER PATIENT DEVELOPED REFLEX SYMPATHETIC DYSTROPHY AFTER SCREW FIXATION OF THE SECOND PROXIMAL PHALANX BASE WHICH WAS TREATED WITH OCCUPATIONAL THERAPY AND NERVE BLOCKS. AFTER A 2-MONTH FOLLOW-UP EVALUATION IT WAS NOTED THAT THE PATIENT HAD RADIAL SUBLUXATION OF THE RIGHT THIRD, FOURTH, AND FIFTH DIGITS, AS WELL AS THE LEFT FIFTH DIGIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645912 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention