BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5762457 · Received June 30, 2016

    Report

    Report Number
    2520274-2016-13323
    Event Type
    Injury
    Date Received
    June 30, 2016
    Report Date
    June 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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. SCHWEIZER, ANDREAS, MD., MAULER, FLAVIAN, MD., VLACHOPOULOS, LAZAROS, MD., NAGY, LADISLAV, MD., & FURNSTAHL, PHILIPP, PHD (2016). COMPUTER-ASSISTED 3-DIMENSIONAL RECONSTRUCTIONS OF SCAPHOID FRACTURES AND NONUNIONS WITH AND WITHOUT THE USE OF PATIENT-SPECIFIC GUIDES: EARLY CLINICAL OUTCOMES AND POSTOPERATIVE ASSESSMENTS OF RECONSTRUCTION ACCURACY. JOURNAL OF HAND SURGERY (2016), 41(1): 59-69. THIS REPORT IS FOR AN UNKNOWN HEADLESS COMPRESSION SCREW/ UNKNOWN QUANTITY/ UNKNOWN LOT NUMBER. (OTHER NUMBER): UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SCHWEIZER, ANDREAS, MD., MAULER, FLAVIAN, MD., VLACHOPOULOS, LAZAROS, MD., NAGY, LADISLAV, MD., & FURNSTAHL, PHILIPP, PHD (2016). COMPUTER-ASSISTED 3-DIMENSIONAL RECONSTRUCTIONS OF SCAPHOID FRACTURES AND NONUNIONS WITH AND WITHOUT THE USE OF PATIENT-SPECIFIC GUIDES: EARLY CLINICAL OUTCOMES AND POSTOPERATIVE ASSESSMENTS OF RECONSTRUCTION ACCURACY. JOURNAL OF HAND SURGERY (2016). SWITZERLAND. THIS ARTICLE DISCUSSED THE RESULTS REGARDING THE ACCURACY OF THE REDUCTION OF SURGICALLY RECONSTRUCTED SCAPHOID NONUNIONS OR FRACTURES USING 3-DIMENSIONAL COMPUTER BASED PLANNING WITH AND WITHOUT PATIENT SPECIFIC GUIDES. THE METHODS USED WAS A COMPUTER-BASED SURGICAL PLANNING PERFORMED WITH COMPUTED TOMOGRAPHY DATE ON 22 PATIENTS COMPARING MODELS OF THE PATHOLOGICAL AND THE OPPOSITE UNINJURED SCAPHOID IN 3 DIMENSIONS. THE AUTHORS STUDIED 22 MEN, FROM 2008 TO 2014, WHO WERE SURGICALLY TREATED WITH SCAPHOID NONUNIONS IN THE MIDDLE THIRD OR AT THE JUNCTION BETWEEN THE MIDDLE PROXIMAL THIRD. THE 22 PATIENTS WERE CATEGORIZED INTO 2 GROUPS: GROUP 1, WERE AGES BETWEEN 18 TO 47, WITH A MEAN AGE OF 27; GROUP 2 WERE AGES BETWEEN 18 AND 41, WITH A MEAN AGE OF 24. GROUP 1 INVOLVED 9 PATIENTS. OF THE 9 PATIENTS, 8 (PATIENTS 1, 2, 3, 4, 5, 6, 7, AND PATIENT 9) RECEIVED THE HCS FIXATION PATIENT 8 RECEIVED THE K-WIRE. IN GROUP 2 (13 PATIENTS), PATIENTS 1, 3, 4, 5, 8, 9, 10, 11, 12, AND 13 WERE FIXED WITH HCS, AND 1, PATIENT 7, RECEIVED BOTH SCREW AND K-WIRE FIXATION. COMPLICATIONS: PATIENT 4 IN GROUP 2 UNDERWENT SCREW REMOVAL OWING TO SLIGHT DISTAL PROTRUSION AT THE SCAPHOTRAPEZIUM-TRAPEZOID JOINT. THIS REPORT IS FOR AN UNKNOWN HEADLESS COMPRESSION SCREW (HCS). THIS COMPLAINT INVOLVES ONE DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416864 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention