BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM

    MDR report key: 7796882 · Received August 20, 2018

    Report

    Report Number
    9680825-2018-00075
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 28, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Removal / Correction Number
    9680825-09-27-2018-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DRILL BIT CODE: 1100101 LOT: 273349 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF 195 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE RETURNED DRILL BIT, RECEIVED ON JULY 25TH, 2018, WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL AND DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK WAS PERFORMED ON THE RETURNED DEVICE COMPARED TO DRILL BITS TAKEN FROM THE STOCK. IT WAS CONFIRMED THAT THE RETURNED DRILL BIT HAS A LOWER CUTTING PERFORMANCE THAN THE DRILL BITS HISTORICALLY MANUFACTURED. FINAL COMMENTS: ORTHOFIX HAS RECEIVED SOME COMPLAINTS FROM THE MARKET OF A LOWER CUTTING PERFORMANCE OF DRILL BITS. ORTHOFIX SRL CONDUCTED AN INVESTIGATION BY PERFORMING TECHNICAL ANALYSIS, MEDICAL EVALUATIONS AND A REVIEW OF THE RISK ANALYSIS. THE RESULT OF THE INVESTIGATION DETERMINED THAT SOME PRODUCTION BATCHES OF DRILL BITS, MANUFACTURED IN A LIMITED PERIOD OF THE YEARS 2017/2018, SHOW A LOWER CUTTING PERFORMANCE COMPARED TO DRILL BITS HISTORICALLY MANUFACTURED. ORTHOFIX DETERMINED THAT ALL DRILL BITS MANUFACTURED IN THAT LIMITED PERIOD OF TIME BE WITHDRAWN FROM THE MARKET (RE. US FDA RECALL ACTION NUMBER 9680825-09-27-2018-003-R AND FSCA201803). ORTHOFIX SRL WOULD LIKE TO INFORM YOU THAT THE DEVICE INVOLVED IN THIS EVENT, BELONGS TO A BATCH INCLUDED IN THE RECALLED LIST. ORTHOFIX SRL WOULD LIKE TO ASSURE THAT DRILL BITS MANUFACTURED BEFORE AND AFTER THE INDICATED PERIOD HAVE OPTIMAL CUTTING PERFORMANCE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 1100101, BATCH NUMBER: 273349, QUANTITY: 1, HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF SURGERY: ON (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "1100101 DRILL 4, 8X180MM # 273349 FROM STERILE KIT 99-91647UE WITH # B1212677 WAS NOT SHARP DURING SURGERY; LEADS TO: HIGH TEMPERATURE, NOT EXACT DIAMETER OF THE HOLE, MORE ANESTHESIA AND LONGER TIME FOR SURGERY; SURGEON IS EXPERIENCED WITH ORTHOFIX DRILLS AND HE DESCRIBED THE DRILL AS EXTREMELY BAD". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (OTHER, SEE EVENT DESCRIPTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: HIGH RISK FOR PIN INFECTION; HIGH RISK FOR NECROSIS AVOIDED THROUGH THE HIGH TEMPERATURE. ON JULY 25, 2018, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: PATIENT INFO: 74 KG, AGE NOT AVAILABLE. EXTRA TIME OCCURRED: ABOUT 20 MINUTES. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DRILL BIT CODE 1100101, LOT 273349 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, 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 NOTIFICATION RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT WAS RECEIVED BY ORTHOFIX (B)(4) ON JULY 31, 2018. THE TECHNICAL INVESTIGATION IS CURRENTLY ONGOING. MEDICAL EVALUATION: THE INFORMATION MADE 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 INVESTIGATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    "HE" INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 1100101; BATCH NUMBER: 273349; QUANTITY: 1; HOSPITAL NAME: (B)(6); SURGEON'S NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "1100101 DRILL 4,8X180MM # 273349 FROM STERILE KIT 99-91647UE WITH # B1212677 WAS NOT SHARP DURING SURGERY; LEADS TO: HIGH TEMPERATURE, NOT EXACT DIAMETER OF THE HOLE, MORE ANESTHESIA AND LONGER TIME FOR SURGERY; SURGEON IS EXPERIENCED WITH ORTHOFIX DRILLS AND HE DESCRIBED THE DRILL AS EXTREMELY BAD". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (OTHER, SEE EVENT DESCRIPTION); THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITION: HIGH RISK FOR PIN INFECTION; HIGH RISK FOR NECROSIS AVOIDED THROUGH THE HIGH TEMPERATURE. ON JULY 25, 2018, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: PATIENT INFO: (B)(6), AGE NOT AVAILABLE; EXTRA TIME OCCURRED: ABOUT 20 MINUTES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639059 DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM JDW ORTHOFIX SRL 1100101 273349

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention