BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ¿3.5MM PLATE LOCKING SCREW 28 MM¿

    MDR report key: 5841448 · Received August 2, 2016

    Report

    Report Number
    1651501-2016-00030
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    April 28, 2016
    Report Date
    July 18, 2016
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    K123000
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 8NOV2016. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: NO LOT NUMBER FOR THE 3.5 MM PLATE-COMPRESSION SCREW; PRODUCT ID: 2830028 WAS PROVIDED THEREFORE THE MANUFACTURING RECORD FROM WITH THE SCREW ORIGINATED COULD NOT BE DETERMINED. HOWEVER, A REVIEW OF THE LOTS RECEIVED FOR THE CORRESPONDING DESIGN DRAWING NUMBER WAS CONDUCTED. FOR (B)(6) 2013 TO PRESENT, NO NON-CONFORMANCES WERE GENERATED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT RECORDS FOR THE SAME PRODUCT (OR SIMILAR PRODUCTS WITHIN THE PRODUCT FAMILY) FOR THE ALLEGED HAZARDOUS SITUATION/FAILURE MODE RECEIVED, DETERMINED TWO (2) TOTAL FOOT SYSTEM 2 PLATE SCREW COMPLAINTS WITH A FAILURE MODE OF BROKEN HAVE BEEN RECEIVED DURING THE LIFETIME OF THE PRODUCT, TYPICALLY 5 YEARS OR WITHIN THE STATED TIMEFRAME. THE CALCULATED COMPLAINT RATE WAS CALCULATED BASED ON THE SALES DATA OF DEVICES AFFECTED BY THE HAZARDOUS SITUATION OR FAILURE MODE, OVER THE NUMBER OF SURGERIES OR UNITS SOLD DURING THE PERIOD OF THE REVIEW. COMPLAINT RATE: (B)(4). CONCLUSION: THE POTENTIAL ROOT CAUSE FOR THE ORIGINAL EVENT WAS IMPROPER POST-OPERATIVE CARE FOLLOWED BY PATIENT. TFS 2 SCREWS FAILED POST-OPERATIVELY IN THE INITIAL EVENT FROM REPEATED HIGH LOADING (LOW-CYCLE FATIGUE), POSSIBLY DUE TO NON-COMPLIANCE WITH POST-OPERATIVE CARE PATIENT INSTRUCTION FOR RESTRICTIONS ON PLACING WEIGHT ON THE FOOT. THE POTENTIAL ROOT CAUSE FOR THE ORIGINAL EVENT WAS IMPROPER POST-OPERATIVE CARE FOLLOWED BY PATIENT.

    Additional Manufacturer Narrative · 1

    THREE OF THE FIVE COMPLAINTS REPORTED TOGETHER ARE DUPLICATES OF EARLIER REPORTED COMPLAINTS. MFR REPORT NUMBERS FOR INITIAL 3 COMPLAINTS: 1651501-2016-00021; 1651501-2016-00022; 1651501-2016-00023. ADDITIONAL INFORMATION RECEIVED 23SEP2016: ¿ INITIAL PROCEDURE ¿ OPEN TREATMENT OF TARSOMETATARSAL JOINT DISLOCATION WITH INTERNAL FIXATION LEFT, PERFORMED (B)(6) 2015. OPERATIVE NOTES PROVIDED DESCRIBE AN UNCOMPLICATED PROCEDURE. ¿ REVISION SURGERY ¿ REMOVE BROKEN PLATE AND SCREW, ORIF FRACTURED MEDIAL CUNEIFORM, PLANTAR EXOSTECTOMY MIDFOOT, ALL LEFT FOOT, PERFORMED (B)(6) 2016. OPERATIVE NOTES PROVIDED. FINDINGS: INTRA-ARTICULAR FRACTURE OF THE MEDIAL CUNEIFORM, FUSION OF THE MET/CUNEIFORM JOINT, ELONGATED HYPERTROPHIC BONE PLANTAR MEDIAL LEFT FOOT. ¿THERE WAS NOTED TO BE A FUSION AT THE PRIOR FIRST MET CUNEIFORM FUSION SITE HOWEVER A DISPLACED FRACTURE AT THE LEVEL OF THE MEDIAL CUNEIFORM WAS NOTED.¿ ¿ CUSTOMER WAS ASKED TO DESCRIBE THE HARDWARE FAILURE. REPLY, ¿NO ADDITIONAL DOCUMENTATION AVAILABLE.¿ ¿ CUSTOMER WAS ASKED IF THERE WERE ANY ISSUES DURING IMPLANTATION AND/OR DURING RECOVERY. WHEN WAS THE ONSET OF SYMPTOMS AND WHAT WERE THE SYMPTOMS. REPLY, ¿(B)(6) 2016 (B)(6) NOTE: PT PRESENTS WITH PAIN TO LEFT FOOT-MEDIAL PLANTAR SURFACE AND DORSAL AREA OVER HARDWARE SITE. PAIN WITH WALKING- IMPROVEMENT WHEN WEARING SHOES. DENIES NUMBNESS BUT ADMITS TO A BURNING SENSATION- AND INCREASED SENSITIVITY TO DORSAL LEFT FOOT. LEFT FOOT: PRIOR SURGICAL SCARS WELL HEALED -NO SIGN OF INFECTION, MEDIAL PLANTAR SURFACE WITH DEFORMITY, SENSITIVE TO LEFT TOUCH OVER DORSAL SCAR.¿ ¿ RELEVANT PATIENT CARE RECORDS AND/OR MEDICAL RECORDS AND IMAGING STUDIES WERE REQUESTED. REPLY, ¿NO ADDITIONAL DOCUMENTATION AVAILABLE.¿ ¿ CUSTOMER WAS ASKED HOW THE PATIENT IS DOING. REPLY, ¿UNKNOWN.¿

    Description of Event or Problem · 1

    THIS EVENT INVOLVED 5 DEVICES USED TOGETHER FOR THE SAME PATIENT, SAME SURGERY. THIS IS REPORT 3 OF 5. THE MFR REPORT NUMBERS: 1651501-2016-00028; 1651501-2016-00029; 1651501-2016-00030; 1651501-2016-00031; 1651501-2016-00032. IT WAS REPORTED THE DEVICE FAILED. "THE SURGEON STATES HARDWARE HAS FAILED." IT WAS REPORTED THE DATE OF EVENT REPORTED WAS THE DATE OF THE REVISION SURGERY. NO INFORMATION REGARDING EVENT CIRCUMSTANCE OR DETAILED PATIENT IMPACT HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493075 ¿3.5MM PLATE LOCKING SCREW 28 MM¿ ¿ORTHOPEDIC MID/HINDFOOT¿ HRS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention