BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5035288 · Received August 27, 2015

    Report

    Report Number
    2520274-2015-15535
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    KTT
    PMA / PMN Number
    PK000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE FOLLOWING SCREWS WERE RECEIVED AND ARE INTACT AND DO NOT SHOW WEAR OR DAMAGE. 413.330 9093279, 413.328 9163474, 413.328 9023971, 413.330 9047837, 413.330 9087963, 413.330 9043286, 413.330 9087963, 413.332 8925092. ALL DHR'S WERE REVIEWED AND NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. THE RMS INVESTIGATION APPROVES THAT THE PLATE BROKE BECAUSE OF MECHANICAL OVERLOADING. THE SCREWS ARE INTACT AND CONCOMITANT DEVIECES. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT 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.

    Additional Manufacturer Narrative · 1

    SEVERAL SCREWS WERE RETURNED TO THE MANUFACTURER. IT IS UNKNOWN WHICH IS THE COMPLAINED SCREW: PART: 413.330, LOT 9093279: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM; MANUFACTURING DATE: 31JULY2014. PART: 413.328, LOT 9163474: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 28MM; MANUFACTURING DATE: 19SEPTEMBER2014. PART: 413.328, LOT 9023971: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 28MM; MANUFACTURING DATE: 14JUNE2014. PART: 413.330, LOT 9047837: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM; MANUFACTURING DATE: 28JUNE2014. PART: 413.330, LOT 9087963 (QUANTITY 2): 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM; MANUFACTURING DATE: 26JULY2014. PART: 413.330, LOT 9043286: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM; MANUFACTURING DATE: 26JUNE2014. PART: 413.332, LOT 8925092: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 32MM; MANUFACTURING DATE: 02APRIL2014. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR ALL POTENTIAL PART/LOTS: MANUFACTURING LOCATION: (B)(4). NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT WAS REPORTED AS (B)(6). DATE OF POST-OPERATIVE PLATE BREAKAGE IS UNKNOWN; HOWEVER, THE BREAKAGE WAS CONFIRMED ON (B)(6) 2015. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 510K: UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT SCREW WERE NOT PROVIDED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A TITANIUM (TI) BROAD LOCKING COMPRESSION PLATE (LCP) IMPLANTED ON (B)(6) 2015. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2015 WHEN IT WAS CONFIRMED THAT THE DEVICE HAD BROKEN. THE IMPLANT WAS REMOVED ON (B)(6) 2015 AND THE PATIENT REVISED WITH ANOTHER IMPLANT. PATIENT REPORTED AS "STABLE" POST-OPERATIVELY. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566747 APPLIANCE, FIXATION, NAIL KTT SYNTHES HAGENDORF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention