BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5185378 · Received October 28, 2015

    Report

    Report Number
    3009450884-2015-10074
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    August 6, 2015
    Report Date
    October 6, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS FOR ONE (1) UNKNOWN SCREW ¿ A TOTAL OF 11 SCREWS WERE RETURNED, HOWEVER IT IS UNKNOWN WHICH OF THE 11 WERE LOCATED IN THE BROKEN SCREW HOLE. (B)(6). (B)(4). PATIENT UNDERGOING REVISION SURGERY. DHR REVIEW: 1X 204.818 ¿ 8926617. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 02.APR.2014. EXPIRY DATE: -. 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. 1X 213.024 ¿ 8967142. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 29.APR.2014. EXPIRY DATE: -. 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. 2X 213.022 ¿ 8962604. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 29.APR.2014. EXPIRY DATE: -. 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. 1X 213.018 ¿ 8939020. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 09.APR.2014. EXPIRY DATE: -. 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. 4X 213.024 ¿ 8967142. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 02.MAY.2014. EXPIRY DATE: -. 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. 1X 213.020 ¿ 8932794. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 07.APR.2014. EXPIRY DATE: -. 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. 1X 213.024S ¿ 9066588. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 18.JUL.2014. EXPIRY DATE: -. 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. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PROCEDURE WAS AN IMPLANT REMOVAL OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL HUMERUS. THE RECON PLATE HAD BEEN BENT TO CONTOUR TO DISTAL HUMERUS; IT THEN APPEARED PLATE HAD BROKEN WHERE IT HAD BEEN BENT. TWO LOCKING COMPRESSION PLATES (LCP) WERE USED TO DOUBLE PLATE. SURGEON REQUESTED TESTING OF PLATE STRENGTH AFTER PLATE BROKE. REVISION SURGERY OCCURRED ON THE (B)(6). THE PRIMARY IMPLANT DATE IS UNKNOWN. THE SURGERY THAT TOOK PLACE ON THE (B)(6) WAS A REVISION DUE TO ONE PLATE BREAKING AND NOT A REMOVAL THAT WAS PLANNED AT THE TIME OF PRIMARY. THE IMPLANT FRACTURED 1-2 DAYS PRIOR TO REVISION. ONLY ONE OF THE TWO LCPS BROKE. THE PATIENT REPORTED THAT THEY DID NOT FALL OR HAVE TRAUMA ASSOCIATED WITH THE IMPLANT FRACTURE, HOWEVER, THE SURGEON DID NOT BELIEVE THAT THIS WAS TRUE. UPON RECEIVING THE ONE BROKEN LOCKING COMPRESSION PLATE IT WAS DETERMINED THAT THE DAMAGED PLATE IS BROKEN AT A SCREW HOLE BUT IT IS UNKNOWN IF THIS SCREW HOLE WAS OCCUPIED AND IF SO, IT IS UNKNOWN WHICH OF THE 11 INTACT SCREWS RETURNED WERE IN THE HOLE. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715236 SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| R