BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES 3.5MM SMALL FRAGMENT CORTICAL SCREWS

    MDR report key: 2915707 · Received January 10, 2013

    Report

    Report Number
    2520274-2013-00239
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWS RECEIVED, ARE WHOLE AND INTACT. THE DRIVE IS IN GOOD CONDITION. THE TOP OF THE HEAD IS LASER MARKED, INDICATING IT WAS MADE PRIOR TO 11/12/2010. THE REMAINDER OF THE SCREW IS FREE OF ANY SIGNIFICANT DAMAGE. ALL OF THE PERTINENT DIMENSIONS ARE WITHIN SPECIFICATIONS. THIS SCREW APPEARS TO BE OF THE 204.810 FAMILY OF SCREWS. BECAUSE NO LOT NUMBER NOR PART NUMBER WAS PROVIDED, A FINITE EVALUATION WAS NOT POSSIBLE. A CONCLUSION CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVAL PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. ADD'L DATA FROM USER FACILITY REPORT: DATE OF REPORT - 12/10/2012; COMMON DEVICE NAME- SMALL FRAGMENT CORTICAL SCREWS (2); DEVICE AVAILABLE FOR EVALUATION- 12/11/2012; INITIAL REPORTER SENT REPORT TO FDA - NO.

    Description of Event or Problem · 1

    RECEIVED USER FACILITY MEDWATCH #340010-2012-89. A COPY WILL BE INCLUDED IN THIS REPORT. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT. ADD'L DATA FROM USER FACILITY REPORT: THE PT ON (B)(6) 2011 HAD A SURGICAL PROCEDURE OF "ARTHROSCOPY LEFT KNEE WITH CHONDROPLASTY OF THE PATELLA." DURING THE PROCEDURE, THE PT HAD TWO 3.5 MM SMALL FRAGMENT CORTICAL SCREWS IMPLANTED IN HER LEFT KNEE. THE PROCEDURE WAS DESCRIBED IN THE OP REPORT AS "A VERTICAL INCISION WAS MADE OVER PATELLAR TENDON. DISSECTION WAS CARRIED DOWN TO THE PATELLA PERITENON WHICH WAS SPLIT LONGITUDINALLY. INSERTION OF TIBIAL TENDON WELL IDENTIFIED AND AN OSTEOTOMY PERFORMED IN SLIGHT V FASHION. THEN WE ROTATED THE OSTEOTOMIZED FRAGMENT MEDIALLY. A K WIRE WAS UTILIZED TO TEMPORARILY FIX POSITION. FOLLOWING THIS, WE THEN PLACED TWO 3.5 MM CORTICAL SCREWS FROM ANTERIOR TO POSTERIOR." ON (B)(6) 2012, THE PT REPORTED TO THE ORTHOPEDIC SURGEON'S OFFICE WITH COMPLAINTS OF HAVING LOTS OF PAIN IN HER LEFT KNEE. ARTHROSCOPIC PICTURES FROM THE OFFICE, SHOWED FAIRLY EXTENSIVE CHANGES OF THE PATELLA FEMORAL CARTILAGE ON THAT SIDE. SHE REPORTED PAIN OVER SCREW SITE AND COULD NOT KNEEL. SHE WAS TAKING EXCESSIVE IBUPROFEN FROM THE PAIN. ON (B)(6) 2012, THE PT WAS TAKEN FOR SAME DAY SURGERY RELATED TO INFRAPATELLAR BURSITIS SECONDARY TO DEEP IMPLANTS. REMOVAL WAS DONE OF THE IMPLANT SCREWS IN THE LEFT KNEE. SMALL AMOUNT FLUID NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15675 SYNTHES 3.5MM SMALL FRAGMENT CORTICAL SCREWS SCREW HWC SYNTHES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R SCREW