BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-LOCKING CORTICAL SCREW

    MDR report key: 2170540 · Received July 21, 2011

    Report

    Report Number
    3025141-2011-00028
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MDR'S: 3025141-2011-00023, 3025141-2011-00027. INITIAL MDR, 3025141-2011-00023, WAS SUBMITTED TO FDA VIA ESG ON (B)(4) 2011, HOWEVER, DURING SUBSEQUENT INTERNAL REVIEW IT WAS DETERMINED A SEPARATE MDR SHOULD BE SUBMITTED FOR THE OTHER MEDICAL DEVICES INVOLVED IN THE INCIDENT. THE INCIDENT ONLY CALLS OUT A LOCKING SCREW AND NON-LOCKING SCREWS. AS NO PART NUMBERS OR SPECIFIC QUANTITIES ARE PROVIDED, ONE MDR FOR EACH TYPE OF DEVICE WILL BE SUBMITTED. THESE ARE MDR NUMBERS 3025141-2011-00027 AND 3025141-2011-00028.

    Additional Manufacturer Narrative · 1

    EVALUATION: RETURNED PARTS WERE VISUALLY EXAMINED UNDER MAGNIFICATION. THE RETURNED PLATE ((B)(4); BATCH 217205) SHOWS NORMAL USE MARKS IN THE LOCKING HOLES AND OUTER SLOTS. THE TWO SLOTS CENTRAL TO THE PLATE WERE NOT USED. ALL RETURNED SCREWS WERE ALSO EXAMINED UNDER MAGNIFICATION AND ONLY ONE SHOWED DAMAGE ((B)(4); BATCH 244208). THIS SCREW SHOWED THREAD DAMAGE AND THE HEAD OF THE SCREW WAS STILL IN THE PLATE AND THEREFORE IT WAS POSSIBLE TO DETERMINE THAT THE SCREW WAS CANTED. THE BREAKAGE DIRECTION CORRESPONDED TO THE THREAD DAMAGE WHICH INDICATES THIS WAS RELATED TO THE INCIDENT AND DID NOT OCCUR DURING INSERTION. THE BREAK SURFACE IS ROUGH WHICH IS CONSISTENT WITH A SINGLE LOAD FAILURE EVENT RATHER THAN A FATIGUE FAILURE. ALL OTHER SCREWS SHOWED NO DAMAGE TO THE THREADS OR THE HEX (SOME HEX WEAR WAS NOTED AS A RESULT OF IMPLANTATION). CONCLUSION: NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING REVIEW OR THE PHYSICAL EXAMINATION OF THE RETURNED PRODUCT THAT WOULD INDICATE A CAUSE FOR THIS EVENT. ONLY THE BROKEN SCREW INDICATED THAT THIS WAS A SINGLE LOADING EVENT WHICH IS CONSISTENT WITH THE EVENT DESCRIPTION WHERE IT STATES THE PATIENT WAS EXERCISING WITH A PUNCHING BAG AND DOING SHOULDER ROLLS. HOWEVER, NO OTHER DEFINITIVE CONCLUSION CAN BE DETERMINED WITH THE AVAILABLE INFORMATION. RELATED MDRS: 3025141-2011-00023; 3025141-2011-00027; 3025141-2011-00029; 3025141-2011-00030; 3025141-2011-00031.

    Description of Event or Problem · 1

    AC ACUMED LOW PROFILE CLAVICLE PLATE WAS IMPLANTED INTO A PATIENT ON (B)(6) 2011. APPROXIMATELY SEVEN WEEKS LATER THE PATIENT EXPERIENCED SOME PAIN WHEN HE PUNCHED A PUNCHING BAG. THIS WAS THEN FOLLOWED BY SOME SHOULDER ROLLS AT WHICH TIME THE PLATE ALLEGEDLY PULLED UP AND CAUSED SOFT TISSUE IRRITATION. A REVISION SURGERY OCCURRED ON (B)(6) 2011 TO REMOVE THE PLATE AT WHICH POINT IT WAS DISCOVERED THAT A LOCKING SCREW WAS BROKEN AND THE NON-LOCKING SCREWS HAD BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-LOCKING CORTICAL SCREW BONE SCREW HRS ACUMED LLC CO-3180 240711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention