BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5100694 · Received September 24, 2015

    Report

    Report Number
    2520274-2015-16106
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. BEREDJIKLIAN, P. K., TAN, V., AND WEILAND, A. J. (2005). ¿INTRA-ARTICULAR FRACTURES OF THE HAND TREATMENT BY OPEN REDUCTION AND INTERNAL FIXATION¿. JOURNAL OF ORTHOPAEDIC TRAUMATOLOGY, 19: 518-523. THIS REPORT IS FOR AN UNKNOWN MODULAR TITANIUM MINI-PLATE AND SCREW SET SPECIFICALLY DESIGNED FOR THE TREATMENT OF HAND FRACTURES /UNKNOWN QUANTITY/UNKNOWN LOT. ADDITIONAL DEVICE PRODUCT CODE: HWC. ARTICULAR REDISPLACEMENT AND COLLAPSE. HARDWARE REMOVAL. 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 JOURNAL ARTICLE, BEREDJIKLIAN, P. K., TAN, V., AND WEILAND, A. J. (2005). ¿INTRA-ARTICULAR FRACTURES OF THE HAND TREATMENT BY OPEN REDUCTION AND INTERNAL FIXATION.¿ JOURNAL OF ORTHOPAEDIC TRAUMATOLOGY, 19: 518-523. THIS IS A RETROSPECTIVE CHART, RADIOGRAPH, AND OPERATIVE REVIEW OF TWENTY-EIGHT PATIENTS WITH DISPLACED INTRA-ARTICULAR FRACTURES OF THE HAND THAT WERE TREATED WITH AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AT TWO DIFFERENT FACILITIES BY TWO DIFFERENT HAND SURGEONS BETWEEN 1999 AND 2001. THE GROUP CONSISTED OF TWENTY-THREE MEN AND FIVE WOMEN WITH AN AVERAGE AGE OF THIRTY-FIVE YEARS (RANGE 18-68). A MODULAR TITANIUM MINI-PLATE AND SCREW SET SPECIFICALLY DESIGNED FOR THE TREATMENT OF HAND FRACTURES WAS USED IN ALL CASES. SCREW DIAMETERS RANGED FROM 1-1.5MM IN MOST FRACTURES. THE LARGER 2-MM SCREWS WERE USED PRIMARILY FOR FRACTURES INVOLVING THE METACARPOPHALANGEAL (MCP) JOINTS. THE AVERAGE FOLLOW UP PERIOD WAS FORTY-SEVEN WEEK (RANGE 26-60). THE AVERAGE TIME TO FRACTURE HEALING WAS 4.7 WEEKS (RANGE 3-6). TWENTY-TWO PATIENTS (79%) HAD EXCELLENT OR GOOD RESULTS, AND SIX PATIENTS (21%) HAD POOR RESULTS. POOR RESULTS WERE DEFINED BY HAVING ONE OR MORE OF THE FOLLOWING COMPLICATIONS INCLUDING: PAIN, NON-UNION, DEFORMITY AFFECTING FUNCTION/COSMESIS OR TOTAL ACTIVE MOVEMENT (TAM) LESS THAN 180 DEGREES, OR (PROXIMAL INTERPHALANGEAL JOINT) PIP MOTION LESS THAN 80 DEGREES. THERE WERE TWO PATIENTS WHO HAD GOOD CLINICAL OUTCOMES BUT REQUIRED A SECOND SURGERY TO REMOVE HARDWARE DUE TO HARDWARE PROMINENCE. THERE WERE NO CASES OF DEEP INFECTION, AND NO PATIENT REQUIRED WOUND COVERAGE BECAUSE OF A SKIN COMPLICATION. THERE WERE NO PATIENTS WITH NONUNION, MALUNION, COMPLEX REGIONAL PAIN SYNDROME OR TENDON RUPTURES. PATIENT 3, A (B)(6) FEMALE WITH A COMMINUTED, OPEN INDEX FRACTURE INVOLVING THE MIDDLE PHALANX AND DISTAL INTERPHALANGEAL JOINT ACHIEVED TAM OF 180 DEGREES BUT HAD POOR CLINICAL OUTCOMES DUE TO ARTICULAR REDISPLACEMENT AND COLLAPSE. THE PATIENT REQUIRED HARDWARE REMOVAL WITH DISTAL INTERPHALANGEAL ARTHRODESIS DUE TO PAIN. THIS IS REPORT 1 OF 8 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MODULAR TITANIUM MINI-PLATE AND SCREW SET SPECIFICALLY DESIGNED FOR THE TREATMENT OF HAND FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630499 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention