BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY WRIST STERILE KIT

    MDR report key: 11161781 · Received January 13, 2021

    Report

    Report Number
    9680825-2021-00005
    Event Type
    Injury
    Date Received
    January 13, 2021
    Report Date
    May 7, 2021
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K141760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE WRIST MODULE CODE 93350 LOT B1268671 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 7 DEVICES WHICH WAS ASSEMBLED IN TWO DIFFERENT BATCHES OF THE GALAXY WRIST STERILE KIT CODE 99-93601 (B1271553 AND B1275972). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON DECEMBER 29, 2020, WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATIONS. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: THE DEVICE IS BROKEN ON THE ALUMINIUM BODY. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS ALSO PERFORMED THE DOCUMENTAL CHECK OF THE RAW MATERIAL USED TO PRODUCE THE BROKEN COMPONENT. NO ISSUE WAS FOUND. FROM THE VISUAL EXAMINATION OF THE BREAKAGE SURFACE, THE TECHNICAL EVALUATION CONCLUDED THAT THE FAILURE OCCURRED IS MAINLY ATTRIBUTABLE TO STRESS CORROSION (COMBINATION OF OXIDATION AND MECHANICAL STRESS). MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED: "IN THIS CASE A 38 YEAR OLD MALE PATIENT HAD THE FIXATOR APPLIED ON (B)(6), 2020. AT AN UNSPECIFIED DATE, DURING SOME SORT OF MANIPULATION IN THE CLINIC, THE FIXATOR BROKE. AFTER THIS A PLASTER CAST WAS APPLIED; WE DO NOT KNOW IF THE FIXATOR WAS REMOVED. THE IMAGE SHOWS THAT THE CENTRAL FIXATOR BODY HAS BROKEN AND THE FIXATOR IS UNUSABLE. WE HAVE NO MORE INFORMATION. THE COMPLAINT FORM STATES THAT THE FRACTURE POSITION WAS LOST. WE DO NOT KNOW WHAT WAS BEING DONE DURING THE "LOOSENING" OF THE FIXATOR". CONCLUSION: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS. THE BREAKAGE OCCURRED IS MAINLY ATTRIBUTABLE TO STRESS CORROSION (COMBINATION OF OXIDATION AND MECHANICAL STRESS). ORTHOFIX SRL HISTORICAL RECORDS SHOW THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-93601 (GALAXY WRIST STERILE KIT). - BATCH NUMBER: B1268671 (THIS BATCH NUMBER IS RELATED TO THE COMPONENT CODE 93350, WRIST MODULE, WHICH IS PART OF THE GALAXY WRIST STERILE KIT CODE 99-93601). - QUANTITY: 1. - HOSPITAL NAME: (B)(6). - SURGEON NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2020. - BODY PART TO WHICH DEVICE WAS APPLIED: WRIST. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 38 YEARS, MALE. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: GALAXY WRIST FIXATOR BROKE DURING LOOSENING AT CLINIC. WHILE ADJUSTING RANGE OF MOTION. PATIENT ENDED UP WITH PAIN COMPLAINT. DEVICE REPLACED BY A PLASTER. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION; HAD TO PUT PLASTER). - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. - COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. - PATIENT'S CURRENT HEALTH CONDITION: PATIENT ENDED UP WITH PAIN. ON DECEMBER 29, 2020, ORTHOFIX RECEIVED THE FOLLOWING ADDITIONAL DETAILS: 1. DATE OF DEVICE BREAKAGE NOT KNOWN BUT PATIENT VISITED CLINIC ON (B)(6) 2020, SURGEON NOTICED DEVICE IS BROKEN. 2. ANOTHER PROCEDURE WAS CARRIED OUT TO STABILISE THE FRACTURE. 3. PATIENT'S CURRENT HEALTH STATUS NOT AVAILABLE. 4. X-RAY REPORTS NOT AVAILABLE WITH US AT PRESENT. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE WRIST MODULE CODE 93350 LOT B1268671 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 7 DEVICES WHICH WAS ASSEMBLED IN TWO DIFFERENT BATCHES OF THE GALAXY WRIST STERILE KIT CODE 99-93601 (B1271553 AND B1275972). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON (B)(6) 2020, IS CURRENTLY UNDER TECHNICAL EVALUATION. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION BECOME AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: (B)(4) (GALAXY WRIST STERILE KIT). BATCH NUMBER: B1268671 (THIS BATCH NUMBER IS RELATED TO THE COMPONENT CODE (B)(4), WRIST MODULE, WHICH IS PART OF THE GALAXY WRIST STERILE KIT CODE (B)(4)). QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: WRIST. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEARS, MALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: GALAXY WRIST FIXATOR BROKE DURING LOOSENING AT CLINIC. WHILE ADJUSTING RANGE OF MOTION. PATIENT ENDED UP WITH PAIN COMPLAINT. DEVICE REPLACED BY A PLASTER. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION; HAD TO PUT PLASTER). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT'S CURRENT HEALTH CONDITION: PATIENT ENDED UP WITH PAIN. ON (B)(6) 2020, ORTHOFIX RECEIVED THE FOLLOWING ADDITIONAL DETAILS: DATE OF DEVICE BREAKAGE NOT KNOWN BUT PATIENT VISITED CLINIC ON (B)(6) 2020, SURGEON NOTICED DEVICE IS BROKEN. ANOTHER PROCEDURE WAS CARRIED OUT TO STABILISE THE FRACTURE PATIENT'S CURRENT HEALTH STATUS NOT AVAILABLE. X-RAY REPORTS NOT AVAILABLE WITH US AT PRESENT. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62394 GALAXY WRIST STERILE KIT GALAXY WRIST STERILE KIT KTT ORTHOFIX SRL 99-93601 UNKNOWN (B1271553 OR B1275972)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention