BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8197840 · Received December 26, 2018

    Report

    Report Number
    8030965-2018-59257
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    April 27, 2018
    Report Date
    November 30, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE; UEMURA, T. ET AL (2018) FLEXOR POLLICIS LONGUS TENDON RUPTURE BY SANDWICHED UNDERLYING VOLAR LOCKING PLATE AND DISTAL RADIUS, JOURNAL OF MEDICAL ULTRASONICS (2018) 45:647¿651 (JAPAN) . THE PRESENT ARTICLE REPORTS A (B)(6) YEAR-OLD MAN WHO FELL FROM A STEPLADDER AND SUSTAINED A RIGHT DISTAL RADIUS FRACTURE. HE UNDERWENT VOLAR LOCKING PLATE FIXATION SURGERY THROUGH A TRANS-FLEXOR CARPI RADIALIS APPROACH WITHOUT MINIMALLY INVASIVE SURGERY AT ANOTHER HOSPITAL. FRACTURES WERE FIXED USING VARIABLE ANGLE-LCP TWO-COLUMN DISTAL RADIUS PLATES 2.4, NARROW (DEPUY SYNTHES JAPAN, JAPAN). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE (B)(6) YEAR-OLD MALE PATIENT EXPERIENCED WRIST PAIN AND SWELLING, LIKE COMPLEX REGIONAL PAIN SYNDROME, WHICH REMAINED AFTER SURGERY. HE WAS CONTINUOUSLY TREATED WITH MEDICATION AND REHABILITATION THERAPY, ALTHOUGH HE HAD NOTICED DIFFICULTY IN RIGHT THUMB MOVEMENT IMMEDIATELY AFTER THE OPERATION. FOUR MONTHS AFTER THE OPERATION, WRIST PAIN AND SWELLING IMPROVED, BUT HE WAS REFERRED TO THE HOSPITAL BECAUSE HE WAS CONSISTENTLY UNABLE TO FLEX THE INTERPHALANGEAL JOINT OF HIS RIGHT THUMB. THE HOSPITAL PERFORMED ULTRASONOGRAPHY EXAMINATION AND FOUND THE PATHOLOGICAL DAMAGE OF THE FPL TENDON AND DURING PASSIVE FLEXION OF THE THUMB, SLIGHT MOVEMENT OF THE SLACK FPL TENDON WAS VISIBLY ONLY DISTAL TO THE DISTAL RIM OF THE PLATE, IN WHICH A DISTAL LOCKING SCREW WAS OBSERVED CLEARLY, BUT OBVIOUSLY DIMINISHED PROXIMALLY IN REAL-TIME ULTRASOUND IMAGING. INTRAOPERATIVELY, THE FPL TENDON WAS FOUND EMBEDDED ENTIRELY UNDER THE PLATE, AND THE DISTAL LOCKING SCREW PENETRATED THE TENDON. THE PROXIMAL STUMP OF THE FPL TENDON WAS SHORTENED PROXIMALLY THROUGH THE WINDOW OF THE PLATE AND WAS CLEARLY OBSERVED ON THE PLATE. THE SCREWS AND PLATE WERE REMOVED. AFTER DEBRIDEMENT OF THE PROXIMAL STUMP OF THE FPL TENDON, 4-CM TENDON DEFECTS WERE REPAIRED USING INTERLACING SUTURES. AT FOLLOW-UP 1 YEAR LATER, HE WAS ABLE TO FLEX HIS THUMB ACTIVELY IN THE SAME MANNER AS HE COULD PRIOR TO THE INJURY. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035198 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention