BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5111042 · Received September 29, 2015

    Report

    Report Number
    2520274-2015-16288
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE NORK, S.E., MD, ROUTT, M.L.C,MD, SIMONIAN, P.T.,MD, TUCKER, M.C.,MD(2000), SIMPLE ANTERIOR PELVIC EXTERNAL FIXATION, THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE, 49;PP.989-994. A DEEP, POLYMICROBIAL PIN SITE INFECTION DEVELOPED IN ONE PATIENT WHO HAD AN ILEOSTOMY ADJACENT TO HIS RIGHT-SIDED PIN, WHICH WAS CONTAMINATED DURING STOMA CARE. THIS WAS SUCCESSFULLY MANAGED WITH FRAME REMOVAL 3 WEEKS AFTER INJURY, OPEN WOUND MANAGEMENT, AND INTRAVENOUS ANTIBIOTICS. HE REMAINED COMFORTABLE AND HAD A LESS THAN 8-MM LOSS OF REDUCTION RADIOGRAPHICALLY. THE SINGLE PIN SITE INFECTION, WHICH OCCURRED ADJACENT TO AND WAS DIRECTLY CONTAMINATED BY AN ILEOSTOMY. ONLY ONE DEEP PIN TRACK INFECTION DEVELOPED, MANDATING EARLY FRAME REMOVAL AND INTRAVENOUS ANTIBIOTIC THERAPY. THIS REPORT IS FOR AN UNKNOWN 5.0MM AO SCHANTZ PIN. ADDITIONAL COMMON DEVICE NAME AND DEVICE PRODUCT CODE: SCREW, FIXATION, BONE ¿ HWC. REVISION SURGERY. THE INVESTIGATION COULD NOT BE COMPLETED NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. NORK, S.E., MD, ROUTT, M.L.C,MD, SIMONIAN, P.T.,MD, TUCKER, M.C.,MD(2000), SIMPLE ANTERIOR PELVIC EXTERNAL FIXATION, THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE, 49;PP.989-994. IN THIS SERIES, A SINGLE-PIN, TWO-BAR ANTERIOR PELVIC EXTERNAL FIXATION CONSTRUCT WAS EVALUATED CLINICALLY FOR ADEQUACY OF REDUCTION, MAINTENANCE OF REDUCTION, ASSOCIATED COMPLICATIONS, AND HEALING. TWO HUNDRED FORTY CONSECUTIVE PATIENTS WERE TREATED OPERATIVELY AT A LEVEL I TRAUMA CENTER FOR PELVIC RING INSTABILITY OVER A PERIOD OF 32 MONTHS (MAY 1993 THROUGH DECEMBER 1995). SIMPLE ANTERIOR SINGLE-PIN, TWO-BAR PELVIC EXTERNAL FIXATION FRAMES (SYNTHES (B)(4)) WERE USED IN 41 (17%) OF THESE PATIENTS. SAPEF WAS CHOSEN FOR THESE PATIENTS WITH UNSTABLE PELVIC INJURIES ON THE BASIS OF THEIR SPECIFIC PELVIC INJURY PATTERNS, LOCAL SOFT TISSUES, AND OVERALL MEDICAL CONDITIONS. SAPEF WAS USED IN PATIENTS WITH PELVIC RING INSTABILITY, ASSOCIATED HEMODYNAMIC INSTABILITY, AND VISCERAL AND/OR OPEN WOUNDS. FLUOROSCOPIC IMAGING WAS USED TO INSERT EACH 5-MM-DIAMETER SCHANTZ PIN (SYNTHES) BETWEEN THE ILIAC TABLES. ALL PINS USED IN THIS STUDY WERE 5.0-MM AO SCHANTZ PINS (SYNTHES). THE PINS WERE CONNECTED TO RADIOLUCENT BARS OF APPROPRIATE LENGTH, AND THE BARS WERE THEN CLAMPED TOGETHER. THE EXTERNAL FIXATOR BARS WERE POSITIONED TO ALLOW FULL HIP FLEXION AND ABDOMINAL CLEARANCE. THERE WERE 21 MALE AND 20 FEMALE PATIENTS, WITH AN AVERAGE AGE OF 31.6 YEARS (RANGE, 13 TO 68 YEARS). FORTY PATIENTS WERE FOLLOWED FOR AN AVERAGE OF 11 MONTHS (RANGE, 6¿24 MONTHS) AFTER INJURY. INITIAL PELVIC CLOSED REDUCTIONS WERE MAINTAINED IN 37 OF 40 PATIENTS (92.5%). THREE PATIENTS HAD EARLY EXTERNAL FIXATION FAILURES ALONE AND SUBSEQUENTLY UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF THE ANTERIOR PELVIC RING (7.5%). IN THIS SERIES, 3 OF 40 PATIENTS HAD EARLY FIXATION FAILURES REQUIRING ADDITIONAL PROCEDURES FOR INTERNAL FIXATION. THE EXTERNAL FIXATION FRAMES WERE MAINTAINED AN AVERAGE OF 7 WEEKS (RANGE, 1¿12 WEEKS). THE THREE EARLY FRAME REMOVALS (,3 WEEKS AFTER INJURY) WERE IN PATIENTS WITH NOTED EARLY FIXATION FAILURE. THESE PATIENTS HAD DIFFERENT PELVIC INJURY PATTERNS. THE FRAMES WERE REMOVED AT THE TIME OF CONVERSION TO INTERNAL FIXATION. FIVE PINS WERE SHOWN ON CT SCAN TO HAVE PENETRATED THE ILIAC CORTEX. IN FOUR PATIENTS, THE ILIAC PIN EXITED THROUGH THE INNER TABLE, AND IN ONE PATIENT THE PIN VIOLATED THE OUTER TABLE OF THE ILIUM. NO ASSOCIATION WAS NOTED BETWEEN MISPLACEMENT OF A PIN AND EARLY LOSS OF REDUCTION. NO IATROGENIC ILIAC FRACTURES RESULTED FROM THE EXTERNAL FIXATION PINS. DESPITE CAREFUL PIN INSERTION TECHNIQUES, FIVE PINS PENETRATED ONE TABLE OF THE ILIUM. A DEEP, POLYMICROBIAL PIN SITE INFECTION DEVELOPED IN ONE PATIENT WHO HAD AN ILEOSTOMY ADJACENT TO HIS RIGHT-SIDED PIN, WHICH WAS CONTAMINATED DURING STOMA CARE. THIS WAS SUCCESSFULLY MANAGED WITH FRAME REMOVAL 3 WEEKS AFTER INJURY, OPEN WOUND MANAGEMENT, AND INTRAVENOUS ANTIBIOTICS. HE REMAINED COMFORTABLE AND HAD A LESS THAN 8-MM LOSS OF REDUCTION RADIOGRAPHICALLY. THE SINGLE PIN SITE INFECTION, WHICH OCCURRED ADJACENT TO AND WAS DIRECTLY CONTAMINATED BY AN ILEOSTOMY, REFLECTS CAREFUL OBSERVANCE OF THESE PRINCIPLES. ONLY ONE DEEP PIN TRACK INFECTION DEVELOPED, MANDATING EARLY FRAME REMOVAL AND INTRAVENOUS ANTIBIOTIC THERAPY. THIS REPORT IS 3 OF 3 FOR (B)(4), FOR AN UNKNOWN 5.0MM AO SCHANTZ PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641235 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention