BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM

    MDR report key: 6219909 · Received January 3, 2017

    Report

    Report Number
    3006126083-2017-10000
    Event Type
    Injury
    Date Received
    January 3, 2017
    Report Date
    December 7, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    KTT
    UDI-DI
    07611819242555
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 245.081, LOT# 8961372. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAY 09, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 NARRATIVE: 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

    A MANUFACTURING EVALUATION AND PRODUCT INVESTIGATION WERE COMPLETED: THE PLATE WAS RECEIVED IN TWO PIECES DUE TO THE BREAKAGE. STRONG SCRATCHES AND MARKS ARE VISIBLE ON THE SURFACE. THE PLATE IS BENT AND NOT IN ITS ORIGINAL STATE. THE DEVICE HISTORY RECORD (DHR) DOES NOT SHOW ANY ABNORMALITIES. EVERYTHING WAS PRODUCED IN SPECIFICATION AS IT SHOULD. MEASUREMENTS OF THE CRITICAL FEATURES WERE TAKEN ON THE BROKEN PART. THIS CONFIRMED THE RESULTS OF THE DHR. THE PLATE WAS PRODUCE AS IT SHOULD BE; NO ABNORMALITY IN PROCESS WAS FOUND. ALL CRITICAL MEASUREMENTS ARE IN SPECIFICATION. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. PER THE TECHNIQUE GUIDE, TO PREVENT SUCH ISSUES, REVERSE BENDING OR USE OF THE INCORRECT INSTRUMENTATION FOR BENDING MAY WEAK THE PLATE AND LEAD TO PREMATURE PLATE FAILURE. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT A LOCKING COMPRESSION RECONSTRUCTION PLATE (LCP) BROKE POST-OPERATIVELY. THE IMPLANTS WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE TO TREAT AN ULNA SHAFT FRACTURE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE IMPLANTS. PATIENT CONDITION AND SURGERY OUTCOME WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) LCP RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Description of Event or Problem · 1

    THE BROKEN PLATE WAS DETECTED DURING ROUTINE CONTROL WITH C-ARM. PATIENT IS NOW OK AND THE FRACTURE IS HEALING. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW 30MM (PART # 204.030, LOT # 9632779, QUANTITY 1); 3.5MM CORTEX SCREW 26MM (PART # 204.026, LOT # 8622798, QUANTITY 1); 3.5MM CORTEX SCREW 24MM (PART # 204.024, LOT # 2643495, QUANTITY 1); 3.5MM CORTEX SCREW 18MM (PART # 204.018, LOT # 8624771, QUANTITY 1); 3.5MM CORTEX SCREW 18MM (PART # 204.018, LOT # 2765803, QUANTITY 1); 3.5MM CORTEX SCREW 18MM (PART # 204.018, LOT # 9081579, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492 3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM APPLIANCE, FIXATION, NAIL KTT SYNTHES RARON 8961372 07611819242555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SIX (6) UNKNOWN CORTICAL SCREWS