BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBS COMPRESSION SCREW

    MDR report key: 10940154 · Received December 3, 2020

    Report

    Report Number
    3010470577-2019-07112
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    July 3, 2019
    Report Date
    December 2, 2020
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    PMA / PMN Number
    K131920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORDS WERE EXAMINED AND BOTH FOUND TO BE COMPLAINTS. UPON EXAMINATION OF THE RETURNED SCREWS, THE BODIES OF THE SCREWS LOOK INDEED TWISTED. BOTH SCREWS' HEADS AND THREADS LOOK INTACT ; THEY WERE BOTH SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT LEAVING ANY DEBRIS BEFORE BEING FULLY INSERTED. OCCURRENCE FOR THIS TYPE OF INCIDENT IS OF 4 SCREWS/21023 IBS COMPRESSION S25 SCREWS SOLD (SALES N° DATED 08/07/2019) =0.019%. THE TWO OTHER OCCURRENCES TOOK PLACE IN 2015 AND 2017 (1 SCREW EACH TIME). CONSIDERING THAT ACCORDING TO THE SURGEON THE PATIENT'S BONE WAS PARTICULARLY HARD; CONSIDERING THAT THE OCCURRENCE IS ACCEPTABLE WITH A MINOR HEALTH OUTCOME, THE ROOT CAUSE FOR THIS INCIDENT IS LINKED TO THE USER, AND NO FIELD ACTION IS DEEMED NECESSARY. IN2BONES WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF INCIDENT AND WILL TRIGGER A FIELD ACTION IF THE OCCURRENCE AND/OR ADVERSE HEALTH OUTCOME INCREASE TO AN UNACCEPTABLE LEVEL. THIS EMDR WAS INITIALLY PREPARED AND SENT TO FDA IN 2019, JULY 15. A FAILURE OCCURRED IN WEBTRADER ELECTRONIC FILING SYSTEM BUT THIS WAS NOT DETECTED BY IN2BONES SAS IMMEDIATELY. IN NOVEMBER 2020, A WEBTRADER CERTIFICATE ISSUE HAS BEEN RESOLVED AND, AT THE SAME TIME, IN2BONES DISCOVERED THE MESSAGES INDICATING THE RECEPTION FAILURES OF SOME EMDRS. IN CONSEQUENCE, THESE EMDRS WERE CORRECTED AND ARE NOW BEING FILED RETROSPECTIVELY.

    Description of Event or Problem · 1

    FOOT SURGERY: THE I.B.S.¿SCREWS ARE OSTEOSYNTHESIS BONE SCREWS, EXISTING IN DIFFERENT MODELS, DIAMETERS AND LENGTHS. THESE MEDICAL DEVICES ARE SOLD STERILE. THE I.B.S.¿ COMPRESSION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR: THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS, OSTEOSYNTHESIS REQUIRING A MONO OR BICORTICAL COMPRESSION. THE SURGERY WAS A MINI CHEVRON OSTEOTOMY FOR TREATMENT OF AN HALLUX VALGUS BETWEEN THE FIRST METATARSAL AND THE DISTAL PHALANX N°1 (M1P1). ACCORDING TO THE SURGEON, THE M1 BONE WAS REALLY HARD; IT WAS PREPARED BEFORE SCREW INSERTION WITH A DRILL 3 TIMES ACCORDING TO THE SURGICAL TECHNIQUE. TWO IBS C S25 SCREWS WERE INSERTED ONE AFTER THE OTHER ON KWIRES. BOTH TIMES, WHEN HE NOTICED THE SCREWS WERE TWISTING, THE SURGEON WAS ABLE TO ADEQUATELY REMOVE THEM. THERE WAS NO ISSUE WHEN IMPLANTING P1 WITH ANOTHER IBS SCREW. THE SURGERY ENDED WITH SATISFACTORY RESULTS FOR THE PATIENT, AFTER A SIGNIFICANT INCREASE OF THE SURGERY DURATION OF 13 MIN (USUAL DURATION FOR THIS TYPE OF INTERVENTION: 30 MIN) EVEN THOUGH THE TWO IBS C SCREWS WERE NOT IMPLANTED AND REPLACED BY A COMPETITOR PRODUCT. THERE WAS NO OTHER CLINICAL CONSEQUENCES AND THE SURGERY ENDED WITH SATISFACTORY RESULTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408131 IBS COMPRESSION SCREW OSTEOSYNTHESIS COMPRESSION SCREW HWC IN2BONES SAS S25 ST020 1902382&1903079

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization