BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3796555 · Received May 7, 2014

    Report

    Report Number
    2520274-2014-11313
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. FRANKE, J., ET AL (2012). INTRAOPERATIVE THREE-DIMENSIONAL IMAGINING IN THE TREATMENT OF ACUTE UNSTABLE SYNDESMOTIC INJURIES. J BONE JOINT SURG AM. 94:1386-90. THIS REPORT IS FOR AN UNKNOWN POSITIONING SCREW. 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. 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 JOURNAL ARTICLE: INTRAOPERATIVE THREE-DIMENSIONAL IMAGINING IN THE TREATMENT OF ACUTE UNSTABLE SYNDESMOTIC INJURIES; FRANKE, J., ET AL (2012). INTRAOPERATIVE THREE-DIMENSIONAL IMAGINING IN THE TREATMENT OF ACUTE UNSTABLE SYNDESMOTIC INJURIES. J BONE JOINT SURG AM. 94:1386-90. OF 2286 ANKLE FRACTURES TREATED OPERATIVELY FROM AUGUST 2001 TO FEBRUARY 2011, 251 CONSECUTIVE CASES (161 MALES, 90 FEMALE OF AVERAGE AGE 43.2 YEARS) WERE IDENTIFIED IN A RETROSPECTIVE CHART REVIEW. FOLLOWING STABILIZATION OF ALL CONCOMITANT BONE INJURIES BY OSTEOSYNTHESIS, AS A STANDARD PROCEDURE, REDUCTION OF THE SYNDESMOSIS WAS PERFORMED WITH USE OF A WEBER CLAMP APPLIED AT THE LEVEL OF THE ANKLE JOINT. FOLLOWING REDUCTION OF THE MORTISE, ONE OR TWO SYNTHES 3.5 MM SMALL FRAGMENT POSITIONING SCREWS WERE INSERTED ACROSS THREE CORTICES FROM LATERAL TO MEDIAL AND FROM POSTERIOR TO ANTERIOR AT AN ANGLE OF 30 DEGREES WITH USE OF THE STANDARD AO TECHNIQUE. IN 82 PATIENTS, MAL-REDUCTION OF THE SYNDESMOSIS OR THE STABILIZED FRACTURES WERE FOUND ON THE THREE-DIMENSIONAL SCAN DESPITE THE FACT THAT THE FRACTURE APPEARED TO BE ADEQUATELY REDUCED. IN ADDITION, DESPITE REPEATED REDUCTION, MAL-ALIGNMENT PERSISTED IN THREE PATIENTS WITH A POSTERIOR MALLEOLAR FRACTURE, IN TWO PATIENTS WITH A TUBERCLE OF CHAPUT FRAGMENT, AND IN ONE PATIENT WITH A MEDIAL MALLEOLAR FRACTURE. IN ONE PATIENT, AN INTRA-ARTICULAR POSITION WAS NOTED FOR MEDIAL MALLEOLAR SCREW. FOUR PATIENTS HAD OTHER MAL-POSITIONS: THE POSITION SCREW DID NOT ENGAGE THE TIBIA IN TWO PATIENTS, THE SCREW WAS TOO LONG IN ONE PATIENT, AND THE POSTERIOR MALLEOLUS WAS NOT ENGAGED BY THE INDIRECT SCREW FIXATION IN THE FOURTH PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN POSITIONING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274415 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention