BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP DRSL DSTL RAD T-PLATE/3H HD/5H SHAFT

    MDR report key: 6793037 · Received August 14, 2017

    Report

    Report Number
    3006126083-2017-10032
    Event Type
    Injury
    Date Received
    August 14, 2017
    Report Date
    July 20, 2017
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 04.115.350, LOT # 7840071: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28.MAR.2012: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED. THE RECEIVED VA-LCP DORS-DRP-T2.4 SHAFT 5HO HE 3HO L5 (04.115.350 / 7840071) WAS FORWARDED TO THE RESPONSIBLE MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THE COMPLAINT. THE PLATE WAS RECEIVED BROKEN IN TWO PIECES AT HOLE 7 WITH VISIBLE MARKS AND SCRATCHES ON THE SURFACE. THERE IS CRACK IN HOLE 3. THE VERTICAL MEASUREMENT OF THE SLOTH WIDTH OF HOLE 7 WAS FOUND TO BE OUT OF SPECIFICATION. THIS IS DUE TO THE BENDING OF THE PLATE AFTER THE RELEASE OF THE PLATE. IN THIS CASE, THE PLATE ONLY NEEDS TO BE BENDED SLIGHTLY IN ORDER FOR THAT MEASUREMENT TO BE OUT OF SPECIFICATION. ALL OTHER MEASUREMENTS THAT COULD BE PERFORMED WERE FOUND TO BE IN SPECIFICATION. CONSIDERING THAT ALL FEATURES WERE MANUFACTURED WITH THE SAME TOOLS AND PARAMETERS, IT IS CONCLUDED, THAT ALL FEATURES ARE MANUFACTURED WITHIN SPECIFICATIONS. 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. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. FURTHERMORE, BELOW LISTED CONCOMITANT DEVICES RECEIVED: 6X 2.4 VA LOCKING SCREWS PART UNK, LOT UNK, 2X 249.912 LOT 8189281/ ADAPTPL 2.4 12HO SST, 1X 02.211.265 LOT H263374/ ADAPTPL 2.4 12HO SST. AS THESE PARTS ARE NOT RESPONSIBLE FOR THE BREAKAGE OF THE PLATE, NO FURTHER INVESTIGATION WILL BE DONE. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 2.4MM TITANIUM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS T-PLATE AND FIVE (5) 2.4MM VA LOCKING SCREWS ON (B)(6) 2017. SURGEON STATED PATIENT MOBILIZED TOO EARLY AND, BECAUSE THE FRACTURE HAD NOT HEALED, CAUSED THE PLATE TO BREAK INTO TWO (2) PIECES DUE TO STRESS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO A 3.5MM METAPHYSEAL PLATE. CONCOMITANT DEVICES REPORTED: 2.4MM VA LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) 2.4MM TITANIUM VA LCP DISTAL RADIUS T-PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: 2.4MM VA LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 6), 2.4MM STRAIGHT PLATE 12 HOLES (PART # 249.912, LOT # 8189281, QUANTITY 2), 2.4/2.7MM VA-LCP T-FUSION PLATE (PART # 02.211.265, LOT # H263374, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572695 2.4MM TI VA-LCP DRSL DSTL RAD T-PLATE/3H HD/5H SHAFT PLATE,FIXATION,BONE HRS SYNTHES RARON 7840071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention