BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PERIARTICULAR PROX HUMERUS PL 10 HOLE/235MM/RT

    MDR report key: 7118813 · Received December 14, 2017

    Report

    Report Number
    2939274-2017-50280
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    November 16, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    PMA / PMN Number
    K082625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. DATE OF IMPLANT IS UNKNOWN, APPROXIMATELY FOUR YEAR AGO. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER CONTACT NUMBER WAS NOT PROVIDED. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW IS PENDING COMPLETION. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 02.123.028, LOT NUMBER: 7041624, PART MFG DATE: 27-SEP-2012, PART EXP. DATE: N/A (FOR STERILE PRODUCT), MANUFACTURING LOCATION: (B)(4): DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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

    IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE WITH DEVICES FROM AN UNKNOWN MANUFACTURER IN THE PROXIMAL HUMERUS. AT SOME POINT POST-OPERATIVELY, APPROXIMATELY FOUR YEARS AGO ON AN UNKNOWN DATE THE PATIENT DEVELOPED A NON-UNION AND WAS IMPLANTED WITH SYNTHES DEVICES [10 HOLE RIGHT PERIARTICULAR PLATE, TEN LOCKING SCREWS AND FOUR CORTEX SCREWS (ONE WAS AN INTERFRAGMENTARY SCREW INDEPENDENT OF THE PLATE)]. AT SOME POINT POST-OPERATIVELY, THE PATIENT DEVELOPED A NONUNION OF THE PERIARTICULAR PROXIMAL HUMERUS DUE TO A BROKEN PLATE. THE PLATE BROKE MIDSHAFT AT THE SECOND FROM THE TOP COMBI HOLE. ON (B)(6) 2017, THE PATIENT UNDERWENT HARDWARE REMOVAL AND A REVISION PROCEDURE THAT WERE SUCCESSFULLY COMPLETED. THIS WAS THE PATIENT¿S THIRD OPERATION OF THIS NONUNION. NO HARM WAS REPORTED TO THE PATIENT. THE PATIENT OUTCOME WAS REPORTED STABLE. DURING THE REVISION, A SCREW HEAD OF ONE UNKNOWN 3.5 MM LOCKING SCREW POPPED OFF AND THAT COMPLAINT IS REPORTED IN (B)(4). CONCOMITANT DEVICES REPORTED: LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 10). CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4) . THIS REPORT IS FOR ONE (1) 3.5 MM LCP PERIARTICULAR PROXHUMERUS PL 10HOLE/235 MM/RT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896038 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 10 HOLE/235MM/RT PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7041624

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention