BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00896

    MDR report key: 3648575 · Received February 26, 2014

    Report

    Report Number
    2520274-2014-00896
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Report Date
    February 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ARTICLE: USING EXTERNAL AND INTERNAL LOCKING PLATES IN A TWO-STAGE PROTOCOL FOR TREATMENT OF SEGMENTAL TIBIAL FRACTURES; CHING-HOU MA, MD, YUA-KUN TU, MD, JIH-HIS YEH, MD, SHIH-CHIEH YANG, MD & CHIN-HSIEN WU, MD; THE JOURNAL OF TRAUMA, INJURY, INFECTION AND CRITICAL CARE, VOLUME 71, NUMBER 3, SEPTEMBER 2011; 614-619. THE JOURNAL OF TRAUMA, INJURY, INFECTION AND CRITICAL CARE, VOLUME 71, NUMBER 3, SEPTEMBER 2011; 614-619. DEVICE IS AN UNKNOWN PLATE, QUANTITY 1. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: USING EXTERNAL AND INTERNAL LOCKING PLATES IN A TWO-STAGE PROTOCOL FOR TREATMENT OF SEGMENTAL TIBIAL FRACTURES. THE TIBIAL SEGMENTAL FRACTURES USUALLY FOLLOW HIGH-ENERGY TRAUMA AND ARE OFTEN ASSOCIATED WITH MANY COMPLICATIONS. WE DESIGNED A TWO-STAGE PROTOCOL FOR THESE COMPLEX INJURIES. THE AIM OF THIS STUDY WAS TO ASSESS THE OUTCOME OF TIBIAL SEGMENTAL FRACTURES TREATED ACCORDING TO THIS PROTOCOL. A PROSPECTIVE SERIES OF 25 CONSECUTIVE SEGMENTAL TIBIAL FRACTURES WERE TREATED USING A TWO-STAGE PROCEDURE. IN THE FIRST STAGE, A LOW-PROFILE LOCKING PLATE WAS APPLIED AS AN EXTERNAL FIXATOR TO TEMPORARILY IMMOBILIZE THE FRACTURES AFTER ANATOMIC REDUCTION HAD BEEN ACHIEVED FOLLOWED BY SOFT-TISSUE RECONSTRUCTION. THE SECOND STAGE INVOLVED DEFINITIVE INTERNAL FIXATION WITH A LOCKING PLATE USING A MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS TECHNIQUE WITH THE LOCKING COMPRESSION PLATE (LCP,) TIBIAL METAPHYSEAL PLATE (SYNTHES) OR AN LISS-PLT PLATE (SYNTHES) THE MEDIAN FOLLOW-UP WAS 32 MONTHS (RANGE, 20¿44 MONTHS). ALL FRACTURES ACHIEVED UNION. THE MEDIAN TIME FOR THE PROXIMAL FRACTURE UNION WAS 23 WEEKS (RANGE, 12¿30 WEEKS) AND THAT FOR DISTAL FRACTURE UNION WAS 27 WEEKS (RANGE, 12¿46 WEEKS). USE OF THE TWO-STAGE PROCEDURE FOR TREATMENT OF SEGMENTAL TIBIAL FRACTURES IS RECOMMENDED. SURGEONS CAN ACHIEVE GOOD REDUCTION WITH STABLE TEMPORARY FIXATION, SOFT-TISSUE RECONSTRUCTION, EASE OF SUBSEQUENT DEFINITIVE FIXATION, AND HIGH UNION RATES. OUR PATIENTS OBTAINED EXCELLENT KNEE AND ANKLE JOINT MOTION, GOOD FUNCTIONAL OUTCOMES, AND A COMFORTABLE CLINICAL COURSE. FROM APRIL 2006 TO MARCH 2008, 25 CONSECUTIVE PATIENTS (15 MEN AND 10 WOMEN), AGED FROM 15 YEARS TO 67 YEARS (MEDIAN AGE, (B)(6)), WITH SEGMENTAL TIBIAL FRACTURES. IN STAGE ONE, AFTER REDUCTION AND LIMITED FIXATION OF THE FRAGMENTS, A LESS INVASIVE STABILIZATION SYSTEM (LISS)-DISTAL FEMUR PLATE (SYNTHES, PAOLI, PA) OR AN EXTERNAL LOCKED PLATE (E-DA, KAOHSIUNG, TAIWAN) WAS APPLIED AS AN EXTERNAL FIXATOR. THE AUTHORS IN THE ARTICLE DISCUSS MULTIPLE SYNTHES DEVICES WHICH HAVE BEEN CAPTURED IN THREE SYNTHES FILES. SYNTHES FILE # (B)(4) DISCUSSES THE (LISS)-DISTAL FEMUR PLATE. SYNTHES FILE # (B)(4) CAPTURES THE LOCKING COMPRESSION PLATE (LCP), TIBIAL METAPHYSEAL PLATE (SYNTHES) AND LISS-PLT PLATE (SYNTHES). THE AUTHORS CITE A SUMMARY OF POSTOPERATIVE FINDINGS FROM OTHER PUBLISHED ARTICLES, WHICH WAS DOCUMENTED IN SYNTHES FILE # (B)(4). THIS SYNTHES FILE IS FOR # (B)(4). THE ARTICLE STATES THE FOLLOWING EVENTS FOR THE LOCKING COMPRESSION PLATE (LCP), TIBIAL METAPHYSEAL PLATE AND LISS-PLT PLATE: DELAYED UNION OF THE DISTAL FRACTURE OCCURRED IN THREE PATIENTS. DELAYED UNION WAS DEFINED AS BONE HEALING THAT OCCURRED WITHOUT ADDITIONAL SURGERY BUT WITH A HEALING TIME THAT EXCEEDED DOUBLE THE NORMAL HEALING TIME OF 3 MONTHS. EVENTUALLY, ALL OF THE FRACTURES UNITED. INITIAL BONE LOSS LESS THAN 2 CM WAS NOTED IN TWO PATIENTS, HOWEVER, THE FRACTURES IN BOTH PATIENTS UNITED 9 WEEKS LATER. VALGUS MALUNION GREATER THAN 5 DEGREES OCCURRED IN TWO PATIENTS. ONE WAS 6 DEGREES AND THE OTHER WAS 7 DEGREES. LIMB LENGTH DISCREPANCY WAS NOTED IN TWO OF THE PATIENTS WITH TRIFOCAL TIBIAL OPEN TYPE III-C FRACTURE (1.5 CM AND 2 CM, RESPECTIVELY) BECAUSE WE DID NOT LENGTHEN THE FRACTURE SITE AT WHICH NEUROVASCULAR ANASTOMOSIS HAD JUST BEEN PERFORMED. BOTH OF THE PATIENTS HAD A LIMPING GAIT. SUFFICIENT INFORMATION WAS NOT PROVIDED FOR THE FILING OF MULTIPLE REPORTS, AS TO WHICH SPECIFIC DEVICE WAS ASSOCIATED WITH THE REPORTED PATIENT EVENTS. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR SYNTHES FILE (B)(4). THE JOURNAL ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117796 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1