BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8357844 · Received February 21, 2019

    Report

    Report Number
    2939274-2019-56568
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    February 7, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. INITIAL ALERT DATE SHOULD HAVE BEEN FEBRUARY 07, 2019 NOT JANUARY 28, 2019 AS PREVIOUSLY 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 AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (B)(4). 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: C. ONG ET AL (2012). OUTCOMES OF OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURES MANAGED WITH LOCKING PLATES. THE AMERICAN JOURNAL OF ORTHOPEDICS. PAGE 407-412. (USA). THE PURPOSE OF THIS STUDY IS TO EVALUATE THE OUTCOMES AND COMPLICATIONS OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF 2-, 3-, AND 4-PART PROXIMAL HUMERUS FRACTURES USING A STANDARD MANAGEMENT PROTOCOL WITH LOCKING PLATES. FROM FEBRUARY 2003 TO JANUARY 2008, 63 PATIENTS WITH ACUTE PROXIMAL HUMERUS FRACTURES MANAGED WITH ORIF AND LOCKING PLATES WERE INCLUDED IN THIS STUDY. SIXTY-THREE ACUTE FRACTURES WERE IDENTIFIED IN 63 ADULTS (19 MEN, 44 WOMEN) MEAN AGE WAS 62 YEARS AND MEAN FOLLOW-UP WAS 19 MONTHS. THERE WERE 12 TWO-PART FRACTURES, 42 THREE-PART FRACTURES, AND 9 FOUR-PART FRACTURES. PROXIMAL HUMERUS LOCKING PLATE (SYNTHES, PAOLI, PENNSYLVANIA) WAS USED TO TREAT THE FRACTURES. PATIENTS WERE EVALUATED 1, 6, 12, 26, AND 52 WEEKS AFTER SURGERY. PATIENTS WERE FOLLOWED FOR A MINIMUM OF 12 MONTHS; WHEN CLINICALLY INDICATED, FOLLOW-UP WAS CONTINUED BEYOND 12 MONTHS. MEAN FOLLOW-UP FOR THE COHORT WAS 19 MONTHS (RANGE, 12-64 MONTHS). THE COMPLICATIONS WERE REPORTED AS FOLLOWS: (B)(6) YEAR-OLD MAN UNDERWENT RESECTION ARTHROPLASTY DUE TO AN EARLY IMPLANT FAILURE. (B)(6) YEAR OLD WOMAN HAD WOUND INFECTION, SECONDARY TO A STAPHYLOCOCCUS EPIDERMIDIS INFECTION, THAT REQUIRED IRRIGATION, DRAINAGE, AND INTRAVENOUS ANTIBIOTICS. (B)(6) YEAR-OLD MAN UNDERWENT REVISION FOR REDUCTION AND FIXATION DUE TO A DISPLACED GREATER TUBEROSITY FRAGMENT THAT WAS FOUND ON CT 1 WEEK AFTER SURGERY. THE POSTOPERATIVE COURSE WAS FURTHER COMPLICATED BY A WOUND INFECTION (ENTEROCOCCUS SPECIES) THAT REQUIRED INTRAVENOUS ANTIBIOTICS AND HARDWARE REMOVAL WITH IRRIGATION AND DEBRIDEMENT. (B)(6) YEAR-OLD MAN, HAD AN INFECTED POSTOPERATIVE HEMATOMA THAT REQUIRED IRRIGATION AND DEBRIDEMENT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT AND OSTEONECROSIS BUT DID NOT REQUIRE REOPERATION. (B)(6) YEAR-OLD FEMALE PATIENT HAD OSTEONECROSIS. (B)(6) YEAR-OLD MALE PATIENT HAD HETEROTOPIC OSSIFICATION. (B)(6) YEAR-OLD MALE PATIENT HAD HARDWARE FAILURE. SEVEN PATIENTS HAD SCREWS THAT PENETRATED THE HUMERAL HEAD. FIVE OF THE 7 HAD THESE SCREWS REMOVED (ROM AND SYMPTOMS IMPROVED SIGNIFICANTLY); THE OTHER 2 WERE ASYMPTOMATIC AND DID NOT REQUIRE HARDWARE REMOVAL. (B)(6) YEAR-OLD WOMAN UNDERWENT SCREW REMOVAL DUE TO SIGNIFICANT GLENOID WEAR CAUSED BY INTRA-ARTICULAR SCREW PENETRATION. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD MALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD MALE PATIENT HAD SCREW CUTOUT. (B)(6) YEAR-OLD FEMALE PATIENT HAD SCREW CUTOUT. THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL HUMERUS LOCKING PLATE AND UNKNOWN SCREWS. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149878 SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention