BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4953443 · Received July 30, 2015

    Report

    Report Number
    2520274-2015-15085
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT IS UNKNOWN IF THE PLATE ACTUALLY BROKE ON (B)(6) 2015 OR IF THIS WAS THE DATE THE BREAKAGE WAS DISCOVERED BY X-RAY. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. ACCORDING TO THE REPORTER, PART NUMBERS COULD BE ONE OF OR A COMBINATION OF THE FOLLOWING: PARTS 04.210.112, 04.210.116, 04.210.118, 2.4MM TI VA LOCKING SCREW STARDRIVE (VARIOUS LENGTHS), 510(K) K103243, DEVICE PRODUCT CODES- HWC AND HRS. PART 04.210.122 2.4MM TI VA LOCKING SCREW STARDRIVE, 510(K) K102694, DEVICE PRODUCT CODE-HRS. PART 401.764, 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, 510(K) K112583, PRODUCT DEVICE CODE-HWC. PART 401.770, 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM, 510(K) K112583, PRODUCT DEVICE CODE-HWC. (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. 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 POTENTIAL PART INFORMATION: PART: 04.210.108, 2.4MM TI VA LOCKING SCREW STARDRIVE 8MM, (B)(4), DEVICE PRODUCT CODES: HWC AND HRS. 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 REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) RADIAL COLUMN PLATE BROKE IN HALF ON TWO WEEKS POST-OPERATIVELY WHILE THE PATIENT¿S LIMB WAS STILL IN A CAST. THE PATIENT REPORTED HEARING A ¿SNAP¿ AND REPORTED EXPERIENCING PAIN. X-RAY(S) TAKEN ON OR AROUND (B)(6) 2015, REVEALED THE SUBJECT PLATE HAD BROKEN (THE SECOND PLATE REMAINED INTACT), NON-UNION OF THE FRACTURE AND REDUCTION COLLAPSE. THE SUBJECT PLATE, A SECOND UNKNOWN PLATE AND AN UNKNOWN QUANTITY OF UNKNOWN SCREWS WERE INITIALLY IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL RADIUS PROCEDURE ON (B)(6) 2015. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 TO REMOVE THE BROKEN PLATE AND ASSOCIATED SCREWS. THE SECOND PLATE AND ASSOCIATED SCREWS WERE NOT REMOVED. IT IS UNKNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED DURING THE REVISION SURGERY. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496991 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention