BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM STERILE

    MDR report key: 18693548 · Received February 13, 2024

    Report

    Report Number
    9680825-2024-00010
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 16, 2024
    Report Date
    May 14, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HRS
    UDI-DI
    18053800897188
    PMA / PMN Number
    K200246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415032 LOT B1670879 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 62 DEVICES. 40 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00006). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415065 LOT B1771062 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 30 DEVICES. 21 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00007 AND 9680825-2024-00008). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415070 LOT B4301328 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2023, WAS COMPRISED OF 20 DEVICES. 8 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00009). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5404532 LOT B1771063 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 25 DEVICES. 18 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00010). TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED ON FEBRUARY 1, 2024, WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. ALL SCREWS WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. IN THE VISUAL CHECK NO ISSUES WERE DETECTED, EXCEPT FOR SIGNS OF USE, AS SCRATCHES, RESIDUES, WEAR OF THREADS. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. CONCLUSIONS: IN THE VISUAL CHECK OF THE RETURNED DEVICES NO ISSUES WERE DETECTED, EXCEPT FOR SIGNS OF USE, AS SCRATCHES, RESIDUES, WEAR OF THREADS. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE EVIDENCE COLLECTED SUGGEST THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS. NO PRODUCT PROBLEM WAS EVIDENCED. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415032 LOT B1670879 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF (B)(4) DEVICES. 40 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00006). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415065 LOT B1771062 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 30 DEVICES. 21 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00007 AND 9680825-2024-00008). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5415070 LOT B4301328 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2023, WAS COMPRISED OF (B)(4) DEVICES. 8 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00009). ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-5404532 LOT B1771063 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF (B)(4) DEVICES. 18 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2024-00010). TECHNICAL EVALUATION THE TECHNICAL EVALUATION ON THE RETURNED DEVICES IS CURRENTLY ON GOING. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODES: 99-5415032 AND 99-5415065 AND 99-5415065 AND 99-5415070 AND 99-5404532 (MFR REPORTS 9680825-2024-00006 AND 9680825-2024-00007 AND 9680825-2024-00008 AND 9680825-2024-00009 AND 9680825-2024-00010 RESPECTIVELY). BATCH NUMBERS: B1670879 AND B1771062 AND B1771062 AND B4301328 AND B1771063. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2024. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMORAL NECK. SURGERY DESCRIPTION: CORRECTION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM AND CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: THE SCREWS ARE DIFFICULT TO ADVANCE INTO THE BONE. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE: OPERATION COMPLETED WITH A COMPETITORS DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 2 HOURS. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND COPY OF X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PRODUCT WAS AT ITS FIRST USE. PATIENT'S CURRENT HEALTH CONDITION: NOT AVAILABLE. ORTHOFIX REF: (B)(4). DISTRIBUTOR REF: JPS_WCH_0124.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODES: 99-5415032 AND 99-5415065 AND 99-5415065 AND 99-5415070 AND 99-5404532 (MFR REPORTS 9680825-2024-00006 AND 9680825-2024-00007 AND 9680825-2024-00008 AND 9680825-2024-00009 AND 9680825-2024-00010 RESPECTIVELY) - BATCH NUMBERS: B1670879 AND B1771062 AND B1771062 AND B4301328 AND B1771063 - HOSPITAL NAME: (B)(6) HOSPITAL - SURGEON'S NAME: DR (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2024 - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMORAL NECK - SURGERY DESCRIPTION: CORRECTION - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM AND CLINICAL (PATIENT) PROBLEM - EVENT DESCRIPTION: THE SCREWS ARE DIFFICULT TO ADVANCE INTO THE BONE THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE: OPERATION COMPLETED WITH A COMPETITORS DEVICE - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 2 HOURS - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS AND COPY OF X-RAY IMAGES ARE NOT AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN - PRODUCT WAS AT ITS FIRST USE - PATIENT'S CURRENT HEALTH CONDITION: NOT AVAILABLE ORTHOFIX REF: (B)(4) DISTRIBUTOR REF: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765820 JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM STERILE JPS SS NON-LOCKING SCREW L32MM DOUBLE START THREAD D4.5MM STERILE HRS ORTHOFIX SRL B1771063 18053800897188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown