BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ¿3.5MM PLATE LOCKING SCREW 28 MM¿

    MDR report key: 5651442 · Received May 12, 2016

    Report

    Report Number
    1651501-2016-00022
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    K123000
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JUNE 17, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; AT THIS TIME, THE ONE-3.5 MM COMPRESSION SCREW AND THREE 3.5 MM PLATE-LOCKING SCREWS HAVE NOT BEEN RETURNED TO INTEGRA FOR FAILURE ANALYSIS. EFFORTS HAVE BEEN MADE TO PROCURE REPRESENTATIVE PRODUCTS, PHOTOS, SURGICAL NOTES, RADIOGRAPHS, OR OTHER OBJECTIVE EVIDENCE TO AID IN THE FAILURE ANALYSIS. IF THE PARTS ARE RETURNED, THE COMPLAINT FILE WILL BE RE-OPENED. DHR REVIEW; 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 DWG-1001-008 WAS CONDUCTED. FOR OCT 2015 TO PRESENT, NO NON-CONFORMANCES WERE GENERATED FOR THIS PRODUCT. COMPLAINTS HISTORY; 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 FIVE TOTAL FOOT SYSTEM 2 PLATE SCREW COMPLAINTS WITH A FAILURE MODE OF ¿BROKEN¿ HAVE BEEN RECEIVED DURING THE LIFETIME OF THE PRODUCT AS SPECIFIED IN THE RISK MANAGEMENT PLAN (RMP), TYPICALLY 5 YEARS OR WITHIN THE STATED TIMEFRAME. CONCLUSION: A ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE ABSENCE OF ACTION DEVICES TO EVALUATE. BASED ON THE DESCRIPTION PROVIDED, POTENTIAL CAUSES FOR THE BREAKAGE COULD BE PRODUCTION RELATED ISSUES SUCH AS RAW MATERIAL OR MACHINING, OR INCORRECT USAGE OF INSTRUMENTATION OR INCORRECT TECHNIQUE DURING INSERTION MAY ALSO HAVE RESULTED IN DAMAGE TO THE SCREWS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A DUPLICATE OF A LATER REPORTED COMPLAINT. MFR REPORT NUMBER FOR THE DUPLICATE IS 1651501-2016-00030. OTHER DUPLICATE MFR REPORT NUMBERS:1651501-2016-00029, 1651501-2016-00031. ADDITIONAL INFORMATION DOCUMENTED IN THE DUPLICATE REPORT: " 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 H & P 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. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 8, 2016. 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 OCT 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.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF THREE REPORTS (SAME PATIENT, SAME SURGERY, DIFFERENT SCREW SIZE). THIS REPORT IS IN REGARDS TO THE 28MM SCREW. OTHER MFG REPORTS#: 1651501-2016-00021, 1651501-2016-00023. IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT HE WAS CONTACTED BY THE DR. FOR A HARDWARE REMOVAL CASE AND UPON INSPECTION OF THE INTRAOPERATIVE FLUOROSCOPY, IT WAS NOTED THAT THERE WERE MULTIPLE BROKEN TFS2 REARFOOT SCREWS WHICH HAD INITIALLY BEEN INSERTED INTO A TFS2 REARFOOT LAPIDUS PLATE IN THE PATIENTS LEFT FOOT. UPON IN SITU INSPECTION, THREE OF THE FOUR SCREWS (1-3.5MM COMPRESSION SCREW AND 3 ¿ 3.5MM PLATE LOCKING SCREWS) PLACED IN THE TFS2 REARFOOT LAPIDUS PLATE HAD FAILED EITHER THROUGH FRACTURE OF THE SCREW THROUGH THE SHAFT OR AT THE HEAD OF THE SCREWS BUT THERE WAS NO FAILURE OF THE TFS2 REARFOOT LAPIDUS PLATE. THE DR. HAD TO REMOVE THE BROKEN IMPLANTS. NO PATIENT INJURY AND NO SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305882 ¿3.5MM PLATE LOCKING SCREW 28 MM¿ ¿ORTHOPEDIC MID/HINDFOOT¿ HRS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention