BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8375162 · Received February 27, 2019

    Report

    Report Number
    8030965-2019-61499
    Event Type
    Injury
    Date Received
    February 27, 2019
    Report Date
    February 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. CORRECTED DATA: DATE OF REPORT/DATE REC¿D BY MFR: INITIAL ALERT DATE SHOULD HAVE BEEN FEBRUARY 15, 2019 NOT JANUARY 30, 2019 AS ORIGINALLY REPORTED. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: SARAHRUDI K ET AL (2009). SURGICAL TREATMENT OF PATHOLOGICAL FRACTURES OF THE SHAFT OF THE HUMERUS. THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE. VOLUME 66. PAGES 789-794. (AUSTRIA). THIS STUDY AIMS TO REPORT AN EXPERIENCE WITH THE TREATMENT OF PATHOLOGIC FRACTURES OF THE HUMERUS SHAFT AND TRY TO CLARIFY INDICATIONS FOR DIFFERENT SURGICAL PROCEDURES. BETWEEN 1992 AND 2007, 54 PATIENTS WHO WERE TREATED FOR PATHOLOGIC FRACTURE OF THE HUMERUS DIAPHYSIS WERE INCLUDED IN THE STUDY. THERE WERE 38 WOMEN AND 16 MEN WITH A MEAN AGE OF 66.5 +/- 12.7 YEARS. 15 PATIENTS WERE TREATED CONSERVATIVELY DUE TO SERIOUS MEDICAL PROBLEMS AND POOR HEALTH CONDITIONS NOT ALLOWING AN OPERATION. THE REMAINING 39 PATIENTS WITH A TOTAL OF 41 FRACTURES UNDERWENT OPERATIVE TREATMENT. A TOTAL OF 22 OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURES IN 21 PATIENTS AND 19 INTRAMEDULLARY (IM) FIXATIONS IN 19 PATIENTS WERE PERFORMED (ONE PATIENT RECEIVED ORIF ON ONE HUMERUS AND IM FIXATION ON THE OTHER HUMERUS). 15 PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES SOLID HUMERAL NAIL (UHN) FOR IM FIXATION WHILE THE REST WERE FIXATED USING A COMPETITOR¿S DEVICE. FOR INTERNAL PLATE FIXATION, 18 PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES DYNAMIC COMPRESSION PLATE, 2 PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES LOCKING COMPRESSION PLATE, AND 1 PATIENT WAS IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE AS WELL AS AN UNKNOWN SYNTHES Y-PLATE. THE MEDIAN SURVIVAL AFTER THE OCCURRENCE OF THE PATHOLOGIC FRACTURE WAS 2.8 MONTHS (RANGE, 0.2¿ 66.7) FOR ALL PATIENTS. THE SURVIVAL RATE FOR THE SERIES OF 54 PATIENTS WAS 0.24 AFTER 1 YEAR AND 0.09 AFTER 2 YEARS FROM THE INITIAL FRACTURE. ALL THE LIVING PATIENTS ARE AMONG THOSE WITH ORIF. THE AUTHORS DID NOT SPECIFY WHICH DEVICES WERE IMPLANTED FOR EACH PATIENT. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: UNKNOWN PATIENTS SHOWED NO SIGN OF CONSOLIDATION OR BRIDGING ON THE RADIOGRAPHS TAKEN AT A MEAN TIME OF 14.8 WEEKS AFTER THE OPERATION. 1 PATIENT HAD A FAIR RELIEF OF PAIN AFTER INTERNAL FIXATION. 4 PATIENTS HAD POSTOPERATIVE IATROGENIC RADIAL NERVE PALSY AFTER INTERNAL FIXATION. 2 PATIENTS WERE UNABLE TO RECOVER FROM THIS NEUROLOGIC DEFICIT IN WHICH 1 OF THESE PATIENTS RADIAL NERVE PALSY WAS CAUSED BY A POSTOPERATIVE HEMATOMA AND REQUIRED REOPERATION. THE NERVE, HOWEVER, DID NOT RECOVER AND THE NEUROLOGIC DEFICIT REMAINED UNTIL THE PATIENT¿S DEATH, 2 WEEKS AFTER THE REVISION SURGERY. 1 PATIENT RECOVERED COMPLETELY 2 MONTHS AFTER REVISION. 1 PATIENT REGAINED COMPLETE RECOVERY AT 3 WEEKS AFTER THE OPERATION. 1 PATIENT HAD A STRESS RISER LED TO REFRACTURE OF THE HUMERUS AT THE DISTAL END OF THE DYNAMIC COMPRESSION PLATE 83 DAYS AFTER PRIMARY STABILIZATION AND REQUIRED REOPERATION. 1 PATIENT STILL HAD PAIN AT THE LAST FOLLOW UP AFTER INTRAMEDULLARY FIXATION. 2 PATIENTS HAD INADEQUATE INTRAMEDULLARY STABILIZATION RESULTING IN INSTABILITY AND NONUNION. 1 OF THE PATIENTS HAD AN INCORRECT INDICATION FOR IM STABILIZATION SINCE THE FRACTURE WAS LOCATED AT THE DISTAL ONE-FIFTH OF THE HUMERUS AND COULD NOT BE SUFFICIENTLY STABILIZED BY THE NAIL. 1 PATIENT HAD A LOCAL PROGRESSION OF THE RESIDUAL TUMOR 200 DAYS AFTER INTRAMEDULLARY FIXATION. THE PATIENT REQUIRED A FOLLOWING PROCEDURE WITH TUMOR CURETTAGE AND CEMENTATION. A (B)(6) YEAR-OLD WOMAN WHO HAD BREAST CARCINOMA HAD A POSTOPERATIVE RADIOGRAPH DONE 3 MONTHS AFTER CLOSED REDUCTION AND INTRAMEDULLARY NAILING SHOWED THAT THE FRACTURE HAS NOT HEALED. A (B)(6) YEAR-OLD WOMAN WHO HAD KIDNEY CARCINOMA HAD A POSTOPERATIVE RADIOGRAPH DONE 1 MONTH AFTER OPEN REDUCTION AND INTERNAL PLATE FIXATION AND USE OF CEMENT, SHOWED NO SIGN OF CONSOLIDATION. 1 PATIENT HAD A LOOSENING OF THE SCREWS AT THE DISTAL END OF A DYNAMIC COMPRESSION PLATE 6 DAYS AFTER OPERATION. THIS REPORT IS FOR UNKNOWN SYNTHES Y-PLATE SCREWS. IT CAPTURES NO SIGN OF CONSOLIDATION OR BRIDGING ON THE RADIOGRAPHS, PAIN, IATROGENIC RADIAL NERVE PALSY. THIS IS REPORT 4 OF 6 FOR (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167749 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention