BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM

    MDR report key: 16543987 · Received March 15, 2023

    Report

    Report Number
    9680825-2023-00013
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 24, 2023
    Report Date
    June 1, 2023
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DEVICE CODE 1100701 BATCH 304836 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018 WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED REGARDING THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION ON 18TH APRIL 2023 ORTHOFIX RECEIVED FOR ANALYSIS FROM THE CUSTOMER: - ONE DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM CODE 1100701 BATCH 304836 (INSTEAD OF A DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT CODE 1-1100101 AS INITIALLY COMMUNICATED). THE RETURNED DRILL BIT, ITEM CODE 1100701, BATCH 304836, WAS EXAMINED BY ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL, AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE DRILL BIT IS DAMAGED, WITH HEAVY SIGNS OF WEAR. THE DIMENSIONAL CHECK PERFORMED WHERE POSSIBLE DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK PERFORMED CONFIRMED THE LOWER PERFORMANCE OF THE DRILL BIT, COMPARED TO THE PERFORMANCE OF A NEW DRILL BIT. THIS IS DUE TO THE WORN CONDITIONS OF THE DEVICE RETURNED. MEDICAL EVALUATION A MEDICAL EVALUATION OF THE EVENT WAS NOT POSSIBLE AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAY IMAGES HAVE BEEN MADE AVAILABLE. FINAL COMMENTS THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE HEAVY SIGNS OF DAMAGE AND REDUCED PERFORMANCES OF THE DEVICE INVOLVED ARE DUE TO THE WORN CONDITIONS OF CUTTING SHAPE/EDGE OF THE DRILL BIT. PLEASE SEE BELOW AN EXTRACT OF THE RELEVANT IFU PQRMD, INDICATING THE INSTRUCTIONS TO FOLLOW FOR INSPECTION OF REUSABLE DEVICES. CUTTING INSTRUMENTS MUST BE CHECKED FOR SHARPNESS. POSSIBLE DAMAGE: DULL SHARPS, BLUNT AND/OR DULL CUTTING FLUTES, BENT TIP. PREVENTION: REGULAR FUNCTIONAL CHECK AND VISUAL INSPECTION. RECOMMENDATIONS: IN CASE OF FAILURE, THE INSTRUMENT MUST BE REPLACED AND NOT BE USED. ACCORDING TO THE ABOVE INSTRUCTIONS, AS THE DRILL BIT INVOLVED IN THIS EVENT SHOWED CLEAR SIGNS OF WEAR, IT SHOULD HAVE BEEN DISCARDED AND REPLACED WITH A NEW ONE, DURING PRE-USE FUNCTIONAL AND VISUAL INSPECTION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL RECORDS, AS THE LOT NUMBER OF THE DEVICE INVOLVED HAS NOT BEEN MADE AVAILABLE. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES 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 · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: DR. (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2023 - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA - SURGERY DESCRIPTION: NA - PATIENT'S INFORMATION: MALE - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: UNFUNCTIONAL DRILL: DURING THE SURGERY, THE 4.8MM DRILL WAS NOT SHARP ENOUGH TO BE INSERTED INTO THE BONE PROPERLY. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 15 MINUTES AND INFECTION RISKS POST-OP - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE - THE PROBLEM DID NOT OCCUR DURING THE FIRST USE OF THE DEVICE - PATIENT'S CURRENT HEALTH CONDITION: NOT KNOWN FURTHER INFORMATION RECEIVED ON 1 MARCH 2023: -THE DRILL BIT WAS USED WITH A TL-HEX TRAUMA SYSTEM -THE DRILL BIT FAILURE GENERATED ONLY HEAT -THE SURGERY WAS FINALIZED SUCCESSFULLY -PATIENT'S CURRENT HEALTH CONDITION: NORMALLY MANUFACTURER REFERENCE NUMBER: (B)(4) DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA SURGERY DESCRIPTION: NA. PATIENT'S INFORMATION: MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: UNFUNCTIONAL DRILL: DURING THE SURGERY, THE 4.8MM DRILL WAS NOT SHARP ENOUGH TO BE INSERTED INTO THE BONE PROPERLY. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 15 MINUTES AND INFECTION RISKS POST-OP. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. THE PROBLEM DID NOT OCCUR DURING THE FIRST USE OF THE DEVICE. PATIENT'S CURRENT HEALTH CONDITION: NOT KNOWN. FURTHER INFORMATION RECEIVED ON 1 MARCH 2023: THE DRILL BIT WAS USED WITH A TL-HEX TRAUMA SYSTEM. THE DRILL BIT FAILURE GENERATED ONLY HEAT. THE SURGERY WAS FINALIZED SUCCESSFULLY. PATIENT'S CURRENT HEALTH CONDITION: NORMALLY. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914009 DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM DRILL BIT DIAMETER 4.8 MM LENGTH 280 MM JDW ORTHOFIX SRL 1100701 304836

    Patients

    Seq Age Sex Outcome Treatment
    1 Male