BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3904966 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12033
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 3.0 MILLIMETER CANNULATED HEADLESS COMPRESSION SCREW. (B)(6). 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, GHOLSON, J., BAE, D., ZURAKOWSKI, D., AND WATERS, P. (2011). SCAPHOID FRACTURES IN CHILDREN AND ADOLESCENTS: CONTEMPORARY INJURY PATTERNS AND FACTORS INFLUENCING TIME TO UNION. J BONE JOINT SURG AM, 93, 1210-9. THE AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS OF 351 SCAPHOID FRACTURES THAT HAD BEEN TREATED FROM 1995 TO 2010 TO CHARACTERIZE CONTEMPORARY FRACTURE PATTERNS IN CHILDREN AND ADOLESCENTS AND TO IDENTIFY FACTORS INFLUENCING TIME TO HEALING FOLLOWING BOTH NONOPERATIVE TREATMENT AND OPERATIVE TREATMENT, USING SYNTHES DEVICE 3.0 MILLIMETER CANNULATED HEADLESS COMPRESSION SCREW AND DEVICE OF TWO COMPETITORS. THE MEAN PATIENT AGE WAS 14.6 YEARS (RANGE, SEVEN TO EIGHTEEN YEARS) WITH AVERAGE FOLLOW-UP 25.8 WEEKS (RANGE, THREE TO 227 WEEKS). OF THESE 351 FRACTURES, THIRTY-NINE HAD COMPLETION OF CLINICAL CARE ELSEWHERE OR WERE LOST TO FOLLOW-UP, LEAVING 312 FRACTURES WITH COMPLETE CLINICAL AND RADIOGRAPHIC FOLLOW-UP. NONOPERATIVE TREATMENT CONSISTED OF THE USE OF A LONG ARM THUMB-SPICA CAST FOR THE INITIAL THREE TO SIX WEEKS, FOLLOWED BY A SHORT ARM THUMB-SPICA CAST UNTIL RADIOGRAPHIC HEALING. OPERATIVE TREATMENT FOR ACUTE FRACTURES CONSISTED OF EITHER OPEN REDUCTION AND SCREW FIXATION VIA A VOLAR APPROACH FOR DISPLACED FRACTURES OR PERCUTANEOUS SCREW FIXATION VIA A DORSAL APPROACH FOR NONDISPLACED FRACTURES. OPERATIVE TREATMENT FOR CHRONIC FRACTURES CONSISTED OF OPEN REDUCTION AND SCREW FIXATION COMBINED WITH THE USE OF STRUCTURAL ILIAC CREST OR VASCULARIZED DISTAL RADIAL BONE GRAFT WHEN NECESSARY. THE AUTHORS REPORTED: ONE PATIENT HAD SCREW DISPLACEMENT REQUIRING SURGICAL SCREW REMOVAL, WITH A RESULTANT MALUNION. A SECOND PATIENT HAD PERSISTENT PAIN AND LIMITED WRIST MOTION IN THE SETTING OF A RADIAL STYLOID OSTEOPHYTE, A GANGLION CYST, AN ULNAR STYLOID OSTEOPHYTE, AND A SCAPHOID OSTEOPHYTE. HE UNDERWENT SECONDARY RADIAL STYLOID AND SCAPHOID OSTEOPHYTE EXCISION, ARTHROSCOPIC WRIST DEBRIDEMENT, AND POSTERIOR INTEROSSEOUS NEURECTOMY. FINALLY, TWO PATIENTS DEMONSTRATED OSTEOPHYTES OR OSSEOUS PROMINENCES AT THE SCAPHOID WAIST THAT DID NOT REQUIRE FURTHER SURGICAL TREATMENT. THE AUTHORS DID NOT IDENTIFY WHICH MANUFACTURERS' DEVICE WAS RELATED TO THE FOLLOWING INCIDENTS: ONE PATIENT HAD SCREW DISPLACEMENT REQUIRING SURGICAL SCREW REMOVAL, WITH A RESULTANT MALUNION; ONE MALE PATIENT HAD PERSISTENT PAIN AND LIMITED WRIST MOTION IN THE SETTING OF A RADIAL STYLOID OSTEOPHYTE, A GANGLION CYST, AN ULNAR STYLOID OSTEOPHYTE, AND A SCAPHOID OSTEOPHYTE. HE UNDERWENT SECONDARY RADIAL STYLOID AND SCAPHOID OSTEOPHYTE EXCISION, ARTHROSCOPIC WRIST DEBRIDEMENT, AND POSTERIOR INTEROSSEOUS NEURECTOMY; TWO PATIENTS DEMONSTRATED OSTEOPHYTES OR OSSEOUS PROMINENCES AT THE SCAPHOID WAIST THAT DID NOT REQUIRE FURTHER SURGICAL TREATMENT; AND UNION RATE FOLLOWING SURGERY WAS 96.5 PERCENT (109 OF 113). THIS REPORT IS FOR AN UNKNOWN 3.0 MILLIMETER CANNULATED HEADLESS COMPRESSION SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383854 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention