BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 36MM

    MDR report key: 6745386 · Received July 26, 2017

    Report

    Report Number
    1719045-2017-10706
    Event Type
    Injury
    Date Received
    July 26, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN DEVICE MALFUNCTIONED. ADDITIONAL PRODUCT CODE: HRS. (B)(4). CONCOMITANT PARTS: THERAPY DATE: (B)(6) 2017. VA-LCP DHP 2.7/3.5 (PART: 04.117.807S / LOT: 7987046 QUANTITY 1); CORTSCR Ø3.5 L24 TI (PART: 404.024S / LOT:9165094 / QUANTITY 1); LOCKSCR Ø3.5 SELF-TAP L22 TAN (PART: 412.107S / LOT:9284883 / QUANTITY 1); LOCKSCR Ø3.5 SELF-TAP L24 TAN (PART:412.108S / LOT: L019396 / QUANTITY 1). 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: ARTICLE NUMBER IS 04.211.036 WITH LOT H276887. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 19-JAN-2017. PART #: 04.211.036, LOT#: H276887 (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. QUANTITY (B)(4). COMPONENTS:. 04.211.036.999 - 2.8MM TI SCREW BLANK 36MM LOT H171239 REVIEWED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. BASED UPON THE STG INDICATIONS AND THE FRACTURE PRESENTED BY THE PATIENT, THE PLATES AND SCREWS SUBJECT TO THIS COMPLAINT DO NOT MEET THE DEPUY SYNTHES RECOMMENDED REQUIREMENTS. AS SUCH, THIS REPRESENTS AN OFF-LABEL USE OF THE IMPLANTED DEVICES. ACCORDING TO THE SURGICAL TECHNICAL GUIDE (STG) THE INDICATIONS FOR THE VA-LCP DISTAL HUMERUS PLATES 2.7/3.5 INCLUDE THE FOLLOWING: INTRA-ARTICULAR FRACTURES OF THE DISTAL HUMERUS. SUPRACONDYLAR FRACTURES OF THE DISTAL HUMERUS. NONUNIONS OF THE DISTAL HUMERUS. OSTEOTOMIES OF THE DISTAL HUMERUS (E.G. DUE TO MALUNIONS, DEFORMITIES). THE AO CLASSIFICATION FOR THE FRACTURE SHOWN IN THE PROVIDED 3D RECONSTRUCTION IS A DIAPHYSEAL HUMERUS FRACTURE, CLASSED AS SIMPLE (I.E. THERE IS A SINGLE FRACTURE LINE PRODUCING TWO FRACTURE FRAGMENTS). THE FRACTURE LINE CONCLUDES AN AO FRACTURE CLASSIFICATION OF [12-A1] (SPIRAL)/[12-A2] (OBLIQUE =30°), AS DEPICTED IN SAMPLE IMAGES. 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

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. 04.211.036S / L305856. MANUFACTURING LOCATION: SELZACH. SUPPLIER: FRUEH AG. MANUFACTURING DATE: 15. FEB. 2017 EXPIRY DATE: 01. FEB. 2027 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE ART/LOT: 04.211.036 / H276887 WAS MANUFACTURED IN US, MONUMENT 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

    . DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM, PART NUMBER 04.211.034S, LOT NUMBER L195469). - RECEIVED PARTS: 1 X 04.211.042S / VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L42 TA / LOT NO: UNKNOWN, 1 X 04.211.036S / VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L36 TA / LOT NO: UNKNOWN, 1 X 04.211.034S / VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L34 TA / LOT NO: UNKNOWN, 1 X 04.211.028S / VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L28 TA / LOT NO: UNKNOWN, 1 X 04.117.807S / VA-LCP DHP 2.7/3.5 / LOT NO: 7987046 (CONCOMITANT), 1 X 404.024S / CORTSCR Ø3.5 L24 TI / LOT NO: 9165094 (CONCOMITANT), 1 X 412.107S / LOCKSCR Ø3.5 SELF-TAP L22 TAN / LOT NO: 9284883 (CONCOMITANT), 1 X 412.108S / LOCKSCR Ø3.5 SELF-TAP L24 TAN / LOT NO: L019396 (CONCOMITANT). - AS RECEIVED CONDITION: VA LOCKING SCREWS -> ALL RECEIVED VA LOCKING SCREWS WERE FOUND BROKEN BETWEEN SCREWHEAD AND THREADED SHAFT.THE BROKEN SCREWHEADS ARE STILL LOCKED INTO THE RECEIVED PLATE. PLATE ( CONCOMITANT) -> THE PLATE SHOWS VISUAL SIGNS OF USAGE. FURTHERMORE THE BROKEN SCREW HEADS WERE FOUND LOCKED INTO PLATE HOLES. SCREWS (CONCOMITANT) -> ALL RECEIVED SCREWS WERE FOUND WITH NORMAL WEAR AND TEAR SIGNS. - CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT EIGHT (8) DEVICES WERE RECEIVED FOR INVESTIGATION. ALL FOUR(4) VA LOCKING SCREWS WERE FOUND BROKEN BETWEEN SCREWHEAD AND THREADED SHAFT. THE BROKEN SCREWHEADS ARE STILL LOCKED INTO THE RECEIVED PLATE. THE PLATE SHOWS VISUAL SIGNS OF USAGE. FURTHERMORE, THE BROKEN SCREW HEADS WERE FOUND LOCKED INTO PLATE HOLES. THE THREE (3) RECEIVED CONCOMITANT SCREWS WERE FOUND WITH NORMAL WEAR AND TEAR SIGNS. BASED UPON THE SURGICAL TECHNICAL GUIDE INDICATIONS AND THE FRACTURE PRESENTED BY THE PATIENT, THE PLATES AND SCREWS SUBJECT TO THIS COMPLAINT DO NOT MEET THE DEPUY SYNTHES RECOMMENDED REQUIREMENTS. AS SUCH, THIS REPRESENTS AN OFF-LABEL USE OF THE IMPLANTED DEVICES. THE FOR THE COMPLAINT RELEVANT DIMENSIONS COULD NOT BE CHECKED DUE TO THE DAMAGE. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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: THE REPORTED DEVICES WERE IMPLANTED IN SURGERY FOR DISTAL HUMERAL DIAPHYSEAL FRACTURE ON (B)(6) 2017. THE VA-LCP DISTAL HUMERAL PLATE IN QUESTION WAS USED FOR THE OPERATION. THE REMOVAL SURGERY OF THE ALL IMPLANTS (THE SCREWS AND THE PLATE) WAS PERFORMED ON (B)(6) 2017 BECAUSE IT WAS FOUND THAT ALL THE FOUR INSERTED LOCKING SCREWS 2.7 WERE BROKEN. THE PLATE WAS NOT BROKEN IN THE PRIMARY SURGERY, THE PLATE WAS PLACED AS 180 DEGREE NOT AS POSTEROLATERAL AND ALSO COULD NOT BE PLACED MEDIAL PLATE SINCE THE SURGEON WAS UNABLE TO PERFORM POSITIONING AND REDUCTION DUE TO THE SEVERE SHOULDER AND ELBOW CONTRACTURES OF THE PATIENT. ACCORDING TO THE SURGEON, THE PATIENT COULD NOT MOVE THE ARM PURPOSELY SINCE THE PATIENT HAD THE SEVERE SHOULDER AND ELBOW CONTRACTURES. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO FRAGMENTS WERE GENERATED. THIS COMPLAINT INVOLVES 4 PARTS. CONCOMITANT PARTS: VA-LCP DHP 2.7/3.5 (PART: 04.117.807S / LOT: 7987046 QUANTITY 1); CORTSCR Ø3.5 L24 TI (PART: 404.024S / LOT:9165094 / QUANTITY 1); LOCKSCR Ø3.5 SELF-TAP L22 TAN (PART: 412.107S / LOT:9284883 / QUANTITY 1); LOCKSCR Ø3.5 SELF-TAP L24 TAN (PART:412.108S / LOT: L019396 / QUANTITY 1). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526017 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 36MM SCREW FIXATION BONE HWC SYNTHES SELZACH L305856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention