MAUDE Adverse Event Report: ORTHOFIX SRL DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT

Model Number 1-1100201

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 1-1100201, batch 354382, before the market release.No anomalies have been found.The original lot, manufactured in 2020 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: the device involved in this event was received by orthofix srl, on 8 march 2023.The technical evaluation is in progress.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.

Event Description

The information provided by local distributor indicates: hospital name: (b)(6).Surgeon's name: prof.(b)(6).Date of initial surgery: (b)(6).2023.Body part to which device was applied: tibia.Surgery description: correction.Patient's information: na.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: the drill bit is not sharp enough, which means the surgeon was not able to pass through the bone without burning it.The complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of same model was immediately available to complete surgery.The event did not lead to a delay in the duration of the surgical procedure.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.Patient's current health condition: na.Further information received on 1 march 2023: the drill bit was used with a tl hex trauma kit.The drill bit burnt the bone directly.The surgery was finalized successfully.Manufacturer and distributor reference numbers: (b)(4).

Manufacturer Narrative

Analysis of historical records.Orthofix srl checked the internal records related to the controls made on the device code 1-1100201 batch 354382 before the market release.No anomalies have been found.The original lot, manufactured in 2020 was comprised of (b)(4) devices.According to orthofix srl historical records, no other notifications have been received regarding this specific device lot.Technical evaluation the returned drill bit, received on 8th march 2023, 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 was performed on the returned device compared to drill bit of the same batch taken from the stock.No anomalies were detected.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.

Event Description

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: correction.- patient's information: na.- problem observed during: clinical use on patient/intraoperative.- type of problem: device functional problem.- event description: the drill bit is not sharp enough, which means the surgeon was not able to pass through the bone without burning it.The complaint report form also indicates: - the device failure had adverse effects on patient.- the initial surgery was not completed with the device.- a replacement device of same model was immediately available to complete surgery.- the event did not lead to a delay in the duration of the surgical procedure.- 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.- patient's current health condition: na.Further information received on 1 march 2023: -the drill bit was used with a tl hex trauma kit.-the drill bit burnt the bone directly.-the surgery was finalized successfully.Manufacturer reference number: 2023034.Distributor reference number: (b)(4).

• Brand Name: DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT
• Type of Device: DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo; verona, 37012 ; IT 37012
• MDR Report Key: 16543764
• MDR Text Key: 311294279
• Report Number: 9680825-2023-00009
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1-1100201
• Device Catalogue Number: 1-1100201
• Device Lot Number: 354382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1