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

Model Number 1-1100201

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records: the device involved in this event has not yet been received by orthofix (b)(4).Unfortunately also the code and the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).The technical evaluation will be performed as soon as the device becomes available.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.

Event Description

The information provided by the local distributor indicates: device code: unknown.Batch number: unknown.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: unknown.Surgery description: correction.(b)(6).Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem/clinical (patient) problem.Event description: reamer without grip - dull drill caused heat to patient, some brown black debris of bone, risk of infection and pin loosening.The complaint report form also indicates: the device failure had adverse effects on patient (risk to the prescription).The initial surgery was completed with the device.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 available (orthofix received one x-ray).Patient current health condition: normal at the moment.Note and comments: sharpness of reamer & tip has been an usp (unique selling point) for orthofix for more than 25 years.(b)(4).

Manufacturer Narrative

Analysis of historical records: the device involved in this event has not returned orthofix srl.Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the device involved in this event has not returned to orthofix srl.The technical evaluation will be performed as soon as the device becomes available.Medical evaluation: the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluations performed."i know dr (b)(6) well.He is a very experienced paediatric limb reconstruction surgeon.He makes the comment that orthofix drill bits have always been sharp, and could be relied on.In this case he noted that the drill bit was difficult to use and that there was brown / black debris from the drilling.The bone chips are not normally discoloured.I think that this is clear evidence to support the clinical impression that the drill bit was not sharp.The drilling will have caused a rise in temperature, producing charring to the bone chips and causing necrosis of the surrounding cells.The fixation will for now be strong".Final comments: a technical evaluation of the device involved was not possible as the device has not returned to orthofix srl.The technical evaluation will be performed as soon as the device becomes available.The medical evaluation evidenced as follows: "i know dr (b)(6) well.He is a very experienced paediatric limb reconstruction surgeon.He makes the comment that orthofix drill bits have always been sharp, and could be relied on.In this case he noted that the drill bit was difficult to use and that there was brown / black debris from the drilling.The bone chips are not normally discoloured.I think that this is clear evidence to support the clinical impression that the drill bit was not sharp.The drilling will have caused a rise in temperature, producing charring to the bone chips and causing necrosis of the surrounding cells.The fixation will for now be strong".Referring to previous similar complaints, orthofix srl can assume that also the drill bit involved in this complaint is manufactured by a new supplier, and has a slightly lower cutting performance than the drill bits produced by the previous supplier.However, this difference does not compromise the possibility to complete the drilling step.Orthofix continues monitoring the devices on the market.

Event Description

The information initially provided by the local distributor indicates: device code: unknown.Batch number: unknown.Quantity: 1 hospital name: (b)(6) hospital.Surgeon's name: dr (b)(6).Date of surgery: (b)(6) 2018.Body part to which device was applied: unknown.Surgery description: correction.Patient information: 10 years, female, 28kg, 145cm.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem/clinical (patient) problem.Event description: reamer without grip dull drill caused heat to patient, some brown black debris of bone, risk of infection and pin loosening.The complaint report form also indicates: the device failure had adverse effects on patient (risk to the prescription), the initial surgery was completed with the device, 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 xray images are available (orthofix received one xray).Patient current health condition: normal at the moment.Note and comments: sharpness of reamer & tip has been an usp (unique selling point) for orthofix for more than 25 years.On april 24, 2018 orthofix srl received the following additional information: we tried hard to receive the drill bit back.It did not arrive here.It was meant to be sent after the sterilization but it did not arrive.Device code: 11100201.Boy part to which device was applied: femur.Patient current health condition: normal.Manufacturer reference number: (b)(4).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, italy 37012 ; IT 37012
• MDR Report Key: 7453583
• MDR Text Key: 107102333
• Report Number: 9680825-2018-00036
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 28