BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6368294 · Received March 1, 2017

    Report

    Report Number
    2520274-2017-10680
    Event Type
    Injury
    Date Received
    March 1, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: THERAPY DATES: (B)(6) 2016: 1X PART 04.117.504S (VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108); 1X PART 04.211.014S LOT (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 1X PART 04.211.014S LOT (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 2X PART 04.211.016S LOT 9882518 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9851385 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9328268 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9834436 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.018S LOT 9740066 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 04.211.018S LOT 9877824 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 412.107S LOT 8588751 (LOCKSCR Ø3.5 SELF-TAP L22 TAN); 1X PART 412.108S LOT 8293590 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 1X PART 412.108S LOT 9440360 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 2X PART 412.109S LOT 9249396 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 2X PART 412.109S LOT 9706620 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 1X PART 412.109S LOT 9743802 (LOCKSCR Ø3.5 SELF-TAP L26 TAN). (B)(6). (B)(4): AN UNKNOWN SCREW WAS FOUND TO BE BROKEN POSTOPERATIVELY. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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

    MANUFACTURING EVALUATION AND PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. PLATE WAS RECEIVED IN TWO PIECES. SURFACE SHOWS MARKS AND SCRATCHES. THE PLATE (VA-LCP DIST HUMERUSPL 2.7/3.5 DORSO-LAT / ARTICLE # 04.117.309S / LOT # 9329222) WAS PRODUCE AS IT SHOULD. NO ABNORMALITY IN PROCESS WAS FOUND. 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. ROOT CAUSE FOR THIS BREAKAGE COULD NOT BE DETERMINED. AS IT WAS REPORTED THAT (SIX MONTHS AFTER THE SURGERY, IT WAS FOUND THAT THE VA LCP PLATE WAS BROKEN) WE ASSUME THAT AN OVERLOADING SITUATION COULD HAVE LED TO THIS BREAKAGE. ONE UNKNOWN SCREW WAS RETURNED BROKEN. ONLY SCREW HEAD RETURNED WITHOUT SHAFT. HEAD THREAD IS WORN. NO INVESTIGATION COULD BE PROVIDED ON THIS ARTICLE AS ARTICLE AND LOT NUMBER ARE UNKNOWN. IN ADDITION SHAFT SECTION IS MISSING AND MEASUREMENTS COULD NOT BE TAKEN AS HEAD THREAD IS WORN TOO. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICES WERE USED IN SURGERY FOR HUMERAL DIAPHYSIS FRACTURE AND DISTAL HUMERAL FRACTURE ON (B)(6) 2016. THE SURGEON FIXED WITH BOTH VA LCP (VARIABLE ANGLE LOCKING COMPRESSION PLATE) PLATES AND INSIDE LONG 4 HOLE PLATE. SIX MONTHS AFTER THE SURGERY, IT WAS FOUND THAT THE VA LCP PLATE WAS BROKEN. THE SURGEON COMMENTED THE PATIENT HASN¿T FALLEN DOWN. HE ALSO COMMENTED THAT BECAUSE HE HAD TO INSERT THE PLATE NEAR THE DIAPHYSIS, HE FIXED IT AS BENDING WHEN THE PLATE WAS IMPLANTED. REVISION SURGERY IS PLANNED ON (B)(6) 2017. AN UNKNOWN SCREW WAS FOUND DURING INCOMING INSPECTION, IT IS UNKOWN WHEN THIS SCREW BROKE. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT MEDICAL PRODUCTS: 1X PART 04.117.504S LOT 9303677 (VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108); 1X PART 04.211.014S LOT 9869931 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 1X PART 04.211.014S LOT 9785988 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 2X PART 04.211.016S LOT 9882518 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9851385 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9328268 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S LOT 9834436 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.018S LOT 9740066 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 04.211.018S LOT 9877824 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 412.107S LOT 8588751 (LOCKSCR Ø3.5 SELF-TAP L22 TAN); 1X PART 412.108S LOT 8293590 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 1X PART 412.108S LOT 9440360 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 2X PART 412.109S LOT 9249396 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 2X PART 412.109S LOT 9706620 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 1X PART 412.109S LOT 9743802 (LOCKSCR Ø3.5 SELF-TAP L26 TAN). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNKNOWN SCREW BROKE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153153 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention