MAUDE Adverse Event Report: ORTHOFIX SRL DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM

Model Number 1100101

Device Problem Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

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: na.Patient's information: female.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 system.The drill bit failure generated only heat.The surgery was finalized successfully.Patient's current health condition: normally.Manufacturer reference number and distributor reference number:(b)(4).

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.Please kindly refer also to mfr report number 9680825-2023-00011.

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: na - patient's information: female - 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 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).

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 1100201 batch 01073552 before the market release.No anomalies have been found.The original lot, manufactured in 2015 was comprised of 191 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.Orthofix srl checked the internal records related to the controls made on the device code 1100101 batch 01075841 before the market release.No anomalies have been found.The original lot, manufactured in 2015 was comprised of 260 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 240 mm code 1100201 batch 01073552 - one drill bit diameter 4.8 mm length 180 mm code 1100101 batch 01075841 (instead of one drill bit d.4,8 mm l.240 mm tin coated - quick connect code 1-1100201 and one drill bit d.4,8 mm l.180 mm tin coated - quick connect code 1-1100101 as initially communicated).The returned drill bits, were examined by orthofix srl quality operations department.The devices were subjected to visual, dimensional, and functional check as per orthofix srl specification.The visual check evidenced that the drill bits are 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 bits, compared to the performance of a new drill bit.This is due to the worn conditions of the devices 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 devices involved are due to the worn conditions of cutting shape/edge of the drill bits.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 bits involved in this event showed clear signs of wear, they should have been discarded and replaced with new ones, during pre-use functional and visual inspection.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2023-00011 follow up 1.

• Brand Name: DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM
• Type of Device: DRILL BIT DIAMETER 4.8 MM LENGTH 180 MM
• 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: 16543886
• MDR Text Key: 311753833
• Report Number: 9680825-2023-00012
• 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: 06/01/2023

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: 1100101
• Device Catalogue Number: 1100101
• Device Lot Number: 01075841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female