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.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.

Event Description

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: fracture treatment; - 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: not known.Further information received on 1 march 2023: -the drill bit was used with a galaxy system; -the drill bit burnt the bone directly; -the surgery was finalized successfully; -the involved drill bit is at the hospital.Manufacturer reference number: (b)(4).Distributor reference number: (b)(4).

Event Description

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: fracture treatment - 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: not known further information received on 1 march 2023: -the drill bit was used with a galaxy system -the drill bit burnt the bone directly -the surgery was finalized successfully -the involved drill bit is at the hospital manufacturer reference number: (b)(4) distributor reference number: (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 01040403 before the market release.No anomalies have been found.The original lot, manufactured in 2012 was comprised of 98 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 analysis the returned drill bit, received on 2nd may 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 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.Conclusions 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.

• 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: 16543769
• MDR Text Key: 311747252
• Report Number: 9680825-2023-00010
• 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: 05/29/2023

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: 01040403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1