BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTISCREW CLAMP

    MDR report key: 4938166 · Received July 22, 2015

    Report

    Report Number
    9680825-2015-00024
    Event Type
    Injury
    Date Received
    July 22, 2015
    Report Date
    August 26, 2015
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K113770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 93020 LOT V1375572 (COMPONENT CODE 930026 LOT V1375100) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT OF THE DEVICE CODE 93020, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVAL: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). THE TECHNICAL EVAL WILL BE PERFORMED IF AND AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVAL: THE INFO MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVAL IS CURRENTLY ON GOING AND WILL BE FINALIZED AS SOON AS FURTHER INFO BECOMES AVAILABLE. ORTHOFIX (B)(4) HAD REQUESTED ADDITIONAL INFO ON THE EVENT SUCH AS DATE OF THE INITIAL SURGERY, PT INFO (AGE, SEX, WEIGHT AND PREVIOUS HEALTH CONDITION), CONFIRMATION THAT THE DEVICE FAILURE OCCURRED DURING TREATMENT AND THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, INFO ON PT CURRENT HEALTH CONDITION, COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE PRE AND POST-OPERATIVE XRAYS (INITIAL SURGERY AND REVISION ONE), DEVICE AVAILABILITY FOR THE TECHNICAL EVAL. UNFORTUNATELY THIS INFO HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFO BECOME AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE, RECEIVED ON AUGUST 6, 2015 WAS SENT TO ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT FOR THE TECHNICAL EVALUATION. TECHNICAL EVALUATION: THE RETURNED DEVICE, RECEIVED ON AUGUST 6TH, 2015 WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRI DESIGN AND PRODUCT SPECIFICATIONS. THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK WAS THEN PERFORMED USING ONE 12 MM ROD AND THREE 6MM SHAFT BONE SCREWS TAKEN FROM ORTHOFIX SRL STOCK. THE FUNCTIONAL CHECK OF THE RETURNED DEVICE DID NOT EVIDENCE ANY ANOMALIES, THE ROD AND THE SCREWS ARE BLOCKED IN THE PROPER WAY. THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT THE RETURNED DEVICE STILL WORKS PROPERLY. THE PROBLEM OCCURRED MIGHT HAVE BEEN CAUSED BY A NOT PROPER CLOSURE OF THE DEVICE. ON JULY 30, 2015, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "WE DON'T HAVE ALL THIS DETAILS YOU ARE ASKING FOR. ANYWAY, IT'S JUST A CLAMP THAT DOESN'T WORK. I CAN JUST CONFIRM YOU THAT THE REVISION SURGERY WAS ON (B)(6) 2015." THE METAL RING CLOCKWISE BEFORE LOCKING IT FIRMLY BY TIGHTENING THE CAM WITH THE UNIVERSAL T-WRENCH OR THE 5 MM ALLEN WRENCH.". PLEASE ALSO KINDLY REFER TO THE INSTRUCTIONS INCLUDED IN THE ORTHOFIX SRL GALAXY FIXATION SYSTEM OPERATIVE TECHNIQUE, REF: GF-1102-OPT. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW A SUMMARY OF THE MEDICAL EVALUATION. "IN THIS CASE THE SURGEON WAS USING THE GALAXY FIXATOR TO TREAT A FRACTURE IN AN ELBOW JOINT. THE INFORMATION PROVIDED IS VERY BRIEF AND INCOMPLETE. I WOULD GUESS THAT THE COMPONENT 93020, A MULTISCREW CLAMP, WAS FOUND TO BE NOT FUNCTIONING AS EXPECTED DURING THE PRIMARY SURGERY, AND WAS REPLACED IMMEDIATELY. THEY ARE ASKING WHY THE CLAMP DID NOT LOCK. THE PATIENT IS UNAFFECTED AND TREATMENT IS CONTINUING AS FAR AS WE KNOW, BUT AGAIN WE HAVE NO CONFIRMATION OF THIS. I SUSPECT THAT THE REASON FOR THIS PROBLEM IS TECHNICAL. THE TECHNICAL ANALYSIS CONFIRMS THAT THE MULTISCREW CLAMPS IN QUESTION IS FULLY FUNCTIONAL. THIS TENDS TO CONFIRM OUR VIEW THAT THE PROBLEM HERE WAS TECHNICAL AT THE TIME OF USE." AS SOON AS ORTHOFIX SRL FINALIZES THE INVESTIGATION ON THIS CASE, A FOLLOW UP REPORT INCLUDING THE FINAL COMMENTS FROM THE MANUFACTURER WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS (INFO ALREADY PROVIDED). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 93020 LOT V1375572 (COMPONENT CODE 930026 LOT V1375100) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT OF THE DEVICE CODE 93020, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (INFO ALREADY PROVIDED) THE RETURNED DEVICE, RECEIVED ON AUGUST 6TH, 2015 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) DESIGN AND PRODUCT SPECIFICATIONS. THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK WAS THEN PERFORMED USING ONE 12 MM ROD AND THREE 6 MM SHAFT BONE SCREWS TAKEN FROM ORTHOFIX (B)(4) STOCK. THE FUNCTIONAL CHECK OF THE RETURNED DEVICE DID NOT EVIDENCE ANY ANOMALIES, THE ROD AND THE SCREWS ARE BLOCKED IN THE PROPER WAY. THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT THE RETURNED DEVICE STILL WORKS PROPERLY. THE PROBLEM OCCURRED MIGHT HAVE BEEN CAUSED BY A NOT PROPER CLOSURE OF THE DEVICE. PLEASE FIND BELOW AN EXTRACT OF THE ORTHOFIX (B)(4) INSTRUCTIONS FOR USE LEAFLET FOR GALAXY FIXATION SYSTEM, SECTIONS WARNINGS & PRECAUTIONS, REF: PQ GAL: "THE CLAMP MUST BE CLOSED FIRST MANUALLY BY TURNING THE METAL RING CLOCKWISE BEFORE LOCKING IT FIRMLY BY TIGHTENING THE CAM WITH THE UNIVERSAL T-WRENCH OR THE 5 MM ALLEN WRENCH.". PLEASE ALSO KINDLY REFER TO THE INSTRUCTIONS INCLUDED IN THE ORTHOFIX (B)(4) GALAXY FIXATION SYSTEM OPERATIVE TECHNIQUE, REF: GF-1102-OPT. MEDICAL EVALUATION (INFO ALREADY PROVIDED) THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW A SUMMARY OF THE MEDICAL EVALUATION. "IN THIS CASE THE SURGEON WAS USING THE GALAXY FIXATOR TO TREAT A FRACTURE IN AN ELBOW JOINT. THE INFORMATION PROVIDED IS VERY BRIEF AND INCOMPLETE. I WOULD GUESS THAT THE COMPONENT 93020, A MULTI-SCREW CLAMP, WAS FOUND TO BE NOT FUNCTIONING AS EXPECTED DURING THE PRIMARY SURGERY, AND WAS REPLACED IMMEDIATELY. THEY ARE ASKING WHY THE CLAMP DID NOT LOCK. THE PATIENT IS UNAFFECTED AND TREATMENT IS CONTINUING AS FAR AS WE KNOW, BUT AGAIN WE HAVE NO CONFIRMATION OF THIS. I SUSPECT THAT THE REASON FOR THIS PROBLEM IS TECHNICAL. THE TECHNICAL ANALYSIS CONFIRMS THAT THE MULTI-SCREW CLAMPS IN QUESTION IS FULLY FUNCTIONAL. THIS TENDS TO CONFIRM OUR VIEW THAT THE PROBLEM HERE WAS TECHNICAL AT THE TIME OF USE." FINAL COMMENTS/CONCLUSIONS (NEW INFORMATION): THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT THE RETURNED DEVICE STILL WORKS PROPERLY. THE PROBLEM OCCURRED MIGHT HAVE BEEN CAUSED BY A NOT PROPER CLOSURE OF THE DEVICE. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "IN THIS CASE THE SURGEON WAS USING THE GALAXY FIXATOR TO TREAT A FRACTURE IN AN ELBOW JOINT. THE INFORMATION PROVIDED IS VERY BRIEF AND INCOMPLETE. I WOULD GUESS THAT THE COMPONENT 93020, A MULTI-SCREW CLAMP, WAS FOUND TO BE NOT FUNCTIONING AS EXPECTED DURING THE PRIMARY SURGERY, AND WAS REPLACED IMMEDIATELY. THEY ARE ASKING WHY THE CLAMP DID NOT LOCK. THE PATIENT IS UNAFFECTED AND TREATMENT IS CONTINUING AS FAR AS WE KNOW, BUT AGAIN WE HAVE NO CONFIRMATION OF THIS. I SUSPECT THAT THE REASON FOR THIS PROBLEM IS TECHNICAL. THE TECHNICAL ANALYSIS CONFIRMS THAT THE MULTI-SCREW CLAMPS IN QUESTION IS FULLY FUNCTIONAL. THIS TENDS TO CONFIRM OUR VIEW THAT THE PROBLEM HERE WAS TECHNICAL AT THE TIME OF USE." BASED ON THE RESULTS OF THE TECHNICAL EVALUATION, WHICH CONFIRMED THAT THE RETURNED DEVICE STILL WORKS PROPERLY, AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4)CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS NOT DEVICE RELATED. ORTHOFIX (B)(4) HAD REQUESTED ADDITIONAL INFORMATION ON THE EVENT SUCH AS DATE OF THE INITIAL SURGERY, PATIENT INFORMATION (AGE, SEX, WEIGHT AND PREVIOUS HEALTH CONDITION), CONFIRMATION THAT THE DEVICE FAILURE OCCURRED DURING TREATMENT, INFORMATION ON PATIENT CURRENT HEALTH CONDITION, COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE PRE AND POST-OPERATIVE XRAYS (INITIAL SURGERY AND REVISION ONE). UNFORTUNATELY THIS INFORMATION HAS NOT BEEN MADE AVAILABLE. IN CASE FURTHER INFORMATION BECOMES AVAILABLE ON THE EVENT, ORTHOFIX (B)(4) WILL RE-OPEN THE INVESTIGATION. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF SURGERY: NOT AVAILABLE. SURGERY DESCRIPTION: FRACTURE TREATMENT ELBOW. PT INFO: NOT AVAILABLE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. EVENT DESCRIPTION: SURGEON CALLED (B)(6) TO COME WHEN PT WAS PRESENT TO SEE THAT THE DEVICE WAS ON "OPEN" AND IT WAS NOT POSSIBLE TO BLOCK IT. (THE "CLICK" IN THE MIDDLE OF THE ROUND PIECE DOESN'T HOLD). THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PT (THEY HAD TO REPEAT A SCOPY AND CHANGE THE PIECE AND REPOSITIONING THE EX-FIX). THE SURGERY WAS COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2015). COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAYS ARE NOT AVAILABLE. INFO ON PT CURRENT HEALTH CONDITION: NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF SURGERY: NOT AVAILABLE. SURGERY DESCRIPTION: FRACTURE TREATMENT ELBOW. PATIENT INFORMATION: NOT AVAILABLE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. EVENT DESCRIPTION: SURGEON CALLED (B)(6) TO COME WHEN PATIENT WAS PRESENT TO SEE THAT THE DEVICE WAS ON "OPEN" AND IT WAS NOT POSSIBLE TO BLOCK IT. (THE "CLICK" IN THE MIDDLE OF THE ROUND PIECE DOESN'T HOLD). THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT (THEY HAD TO REPEAT A SCOPY AND CHANGE THE PIECE AND REPOSITIONING THE EX-FIX). THE SURGERY WAS COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2015). COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAYS ARE NOT AVAILABLE. INFORMATION ON PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. ON JULY 30, 2015, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "WE DON'T HAVE ALL THIS DETAILS YOU ARE ASKING FOR. ANYWAY, IT'S JUST A CLAMP THAT DOESN'T WORK. I CAN JUST CONFIRM YOU THAT THE REVISION SURGERY WAS ON (B)(6) 2015.". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475558 MULTISCREW CLAMP MULTISCREW CLAMP KTT ORTHOFIX SRL 93020 V1375572

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention