BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI LCP T-PLATE/3H HEAD 8 HOLE SHAFT

    MDR report key: 5543899 · Received April 4, 2016

    Report

    Report Number
    2520274-2016-11933
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK090047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PARTIAL UDI: (B)(4) LOT UNKNOWN. DATE RETURNED TO MANUFACTURER SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: DURING SURGERY AFTER THE SURGEON CUT THE PLATE TO THE LENGTH TO FIT THE PATIENT THE PLATE BROKE DURING BENDING. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL ON (B)(6) 2016 THAT SOME BROKEN OFF FRAGMENTS WERE LEFT IN THE PATIENT. AS PER DEVICE REPORT THE PLATE SUPPOSED TO BE ARTICLE AND LOT NUMBER 04.114.007 / LOT 8171172. THE INVESTIGATION SHOWS THE PLATE TO BE A LOCKING T-PLATE 1.5 SHAFT 8HO HE 3HO TI WITH ARTICLE NUMBER 04.116.006 AND UNKNOWN LOT NUMBER. THE LOT NUMBER 8171172 IS UNKNOWN AND DOES NOT MATCH WITH ANY SYNTHES PLATE. THE PLATE IS CUT IN HALF AT THE FOURTH SHAFT HOLE. THE LEFT HEAD LINK IS BROKEN OFF AND NO FRAGMENTS ARE MISSING. THE LEFT HEAD LINK IS INTACT BUT WAS BENT FROM AN ORIGINAL 90 DEGREES ANGLE IN AN APPROX. 120 DEGREES ANGLE. THE LEAFLET ¿IMPORTANT INFORMATION¿ ATTACHED TO EVERY IMPLANT REFERS AT POINT 3 TO THE BENDING OF IMPLANTS: ¿CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. IF THE SHAPE OF THE IMPLANT MUST BE ALTERED, THE DEVICE SHOULD NOT BE BENT SHARPLY, BENT BACKWARDS, NOTCHED, OR SCRATCHED. SUCH MANIPULATIONS, IN ADDITION TO ALL OTHER IMPROPER HANDLING OR USE, CAN PRODUCE SURFACE DEFECTS AND/OR CONCENTRATE STRESS IN THE CORE OF THE IMPLANT. THIS IN TURN MAY EVENTUALLY CAUSE THE PRODUCT TO FAIL.¿ WE DETERMINE THE BREAKAGE TO BE CAUSED DURING A MECHANICAL OVERLOADING SITUATION. NO PRODUCT RELATED ISSUE WAS IDENTIFIED OR CONFIRMED; THE BREAKAGE WAS DETERMINED TO BE CAUSED DURING A MECHANICAL OVERLOADING SITUATION. BRAND NAME UPDATED BASED ON PART RETURNED. 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

    (B)(6). THE REPORTED LOT NUMBER (8171172) CANNOT BE VERIFIED AGAINST THE AVAILABLE PART NUMBER FOR THE PRODUCT. THEREFORE, THE ASSOCIATED FIELDS FOR LOT AND UDI HAVE BEEN LEFT BLANK. (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD REVIEW: THE ARTICLE AND LOT NUMBER DO NOT MATCH. THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS NOT POSSIBLE. VERIFICATION OF THE ACCURATE LOT NUMBER NEEDS TO BE OBTAINED FOR A REVIEW TO BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE NEW INFORMATION, THE REPORTABILITY OF THIS EVENT WAS RE-REVIEWED AND IT WAS DETERMINED THAT THIS COMPLAINT WAS ALSO REPORTABLE AS AN ADVERSE EVENT, REQUIRING INTERVENTION. 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

    UPDATE 26. APR 2016: DURING DEFINING THE INVESTIGATION REQUIREMENTS ON (B)(6) 2016 THE COMPLAINT HANDLING INVESTIGATOR FOUND OUT THAT THE RECEIVED ARTICLE HAS PART NUMBER 04.114.006 AND NOT 04.117.007 AS MENTIONED ON THE SYNERGY FORM.

    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 UNDERWENT A PLATING PROCEDURE ON (B)(6) 2016. THE SURGEON CUT THE PLATE LENGTH TO FIT THE PATIENT'S BONE; HOWEVER, THE PLATE BROKE AS IT WAS BEING BENT TO INSERT. ANOTHER PLATE WAS AVAILABLE FOR USE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION PERTAINING TO THE PATIENT'S OUTCOME WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016. IT WAS FURTHER REPORTED THAT THE PLATE FRAGMENTED WHEN IT BROKE DURING BENDING AND FRAGMENTS WERE RETAINED IN THE PATIENT. THE SURGERY WAS DELAYED APPROXIMATELY LESS THAN 10 MINUTES DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200910 1.5MM TI LCP T-PLATE/3H HEAD 8 HOLE SHAFT PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention