BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4952420 · Received July 30, 2015

    Report

    Report Number
    2520274-2015-15074
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. SEVERAL SCREWS WERE RETURNED TO THE MANUFACTURER, IT IS UNKNOWN WHICH SCREW WAS INVOLVED IN THE COMPLAINED EVENT. POTENTIALLY INVOLVED SCREWS: PART 213.380; LOT 8142036, PART 213.375; LOT 2820629, PART 213.375; LOT 8773971, PART 213.370; LOT 8674747, PART 213.360; LOT 8674764, PART 213.355; LOT 8728009, PART 213.350; LOT 8640843, PART 213.346; LOT 8243348, PART 213.342; LOT 9999, PART 213.342; LOT 7857468, PART 213.342; LOT 2502085, PART 213.320; LOT 2279180. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR THE RETURNED SCREWS POTENTIALLY ASSOCIATED WITH THE REPORTED EVENT. THE RESULTS ARE AS FOLLOWS: (B)(6). NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: PART 213.380, LOT 8142036: THE THREAD FLANKS AT THE SCREW HEAD ARE DAMAGED. PART 213.375, LOT 2820629: THE THREAD FLANKS AT THE SCREW HEAD ARE DAMAGED. PART 213.375, LOT 8773971: THE SCREW SHOWS WEAR AND TEAR SIGNS. PART 213.370, LOT 8674747: THE SCREW SHOWS WEAR AND TEAR SIGNS. PART 213.360, LOT 8674764: THE SCREW SHOWS WEAR AND TEAR SIGNS. THE HEXAGONAL RECESS IS WORN OUT. PART 213.355, LOT 8728009: THE SCREW SHOWS WEAR AND TEAR SIGNS. PART 213.350, LOT 8640843: THE SCREW SHOWS WEAR AND TEAR SIGNS. PART 213.346, LOT 8243348: THE SCREW SHOWS WEAR AND TEAR SIGNS. PART 213.342, LOT 7857468: THE THREAD FLANKS AT THE SCREW HEAD ARE DAMAGED. PART 213.342, LOT 2502085: THE THREAD FLANKS AT THE SCREW HEAD ARE DAMAGED. PART 213.342, LOT UNKNOWN: THE THREAD FLANKS AT THE SCREW HEAD ARE DAMAGED. THE LASER ETCHING IS NOT READABLE. PART 213.320, LOT 2279180: THE SCREW SHOWS WEAR AND TEAR SIGNS. THE HEXAGONAL RECESS IS WORN OUT. THE MANUFACTURING REVIEW, OF ALL ABOVE MENTIONED DEVICES, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. BASED ON THE AVAILABLE INFORMATION WE CANNOT DETERMINE THE EXACT ROOT CAUSE. IT IS LIKELY THAT THE FAILURE OF THE PLATE WAS DUE TO A MECHANICAL OVERLOAD SITUATION. THE POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY CERTAINLY HAVE PLAYED A CONTRIBUTORY ROLE OF THIS OCCURRENCE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EU REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PATIENT HAD A CONDYLAR PLATE IMPLANTED FOR A FEMORAL FRACTURE. A YEAR AFTER IMPLANTATION IT WAS FOUND THAT THE PLATE HAD BROKEN. THE SURGEON REMOVED THE PLATE AND IMPLANTED A NEW ONE. THERE IS NO FURTHER INFORMATION AT THIS TIME. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495896 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention