MAUDE Adverse Event Report: ORTHOFIX SRL GOTFRIED PC.C.P. NECK SCREW DRIVER

Catalog Number 184000

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 01/25/2020

Event Type  Injury  

Manufacturer Narrative

Technical evaluation.The involved device was received on february 4, 2020 by orthofix (b)(4) quality engineering department.The technical evaluation is in progress.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 are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).

Event Description

The information provided by the local distributor indicates: device code: 184000 (gotfried pc.C.P.Neck screw driver).Batch number: ae0336 (lot marked on the component code 184026).Quantity: 1.Hospital name: (b)(6).Surgeon's name: hr.Dr.(b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient's information: unknown.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: while turning the screwdriver (grip 3) counterclockwise (as shown on page 20 operative technique) the handle loosened from the shaft.To finish the operation they used a plier to turn the shaft, so you see the riffle on the shaft.After the operation they pressed the shaft into the handle.The complaint report form also indicated: the device failure did not have any adverse effects on patient.The initial surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical.Procedure: it needs a extra time for the surgery of minimum 30 minutes.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative report are not available.Copies of the x-ray images are not available.Patient current health conditions: good.Manufacturer ref: (b)(4).

Event Description

The information provided by the local distributor indicates: - device code: 184000 (gotfried pc.C.P.Neck screw driver) - batch number: ae0336 (lot marked on the component code 184026) - quantity: 1 - hospital name: (b)(6).- surgeon's name:(b)(6).- date of initial surgery: (b)(6) 2020.- body part to which device was applied: femur - surgery description: fracture treatment - patient's information: unknown - problem observed during: clinical use on patient/intraoperative - type of problem: device functional problem - event description: while turning the screwdriver (grip 3) counter clockwise (as shown on page 20 operative technique) the handle loosened from the shaft.To finish the operation they used a plier to turn the shaft, so you see the riffle on the shaft.After the operation they pressed the shaft into the handle.The complaint report form also indicated: - the device failure did not have any adverse effects on patient - the initial surgery was completed with the device - the event led to a clinically relevant increase in the duration of the surgical procedure: it needs a extra time for the surgery of minimum 30 minutes - an additional surgery was not required - a medical intervention (outpatient clinic) was not required - copies of the operative report are not available - copies of the x-ray images are not available - patient current health conditions: good manufacturer ref: (b)(4).

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the component code 184000 lot ae1800 (lot laser marked on the component code 184026 is: ae0336) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 6 devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation the returned device, received in assembled conditions on february 4, 2020 was examined by orthofix srl quality engineering department.The returned device was disassembled and all components were subjected to visual and functional check as per orthofix specifications.The visual check confirmed the presence of the signs left by the use of a plier to turn the shaft.The components were then re-assembled and a functional check was performed: - the connection and disconnection with a control screw was performed (as reported at page 20 of the operative technique, re.Pm_pcp).No anomalies have been found.The results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The cause of the problem remains unknown.Medical evaluation the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.- january 29, 2020: "a pc.C.P operation should normally take 30 to 45 minutes.The wording is not completely clear, but as far as i can see the report states that there was a delay of at least 30 minutes.I do not think that the patient came to any significant harm, but 30 minutes is normally our threshold for a delay being significant.In this case 30 minutes is nearly 50% of the expected operating time".- february 23, 2020 with the results of the technical evaluation: "as this was reported grip 3 of the screwdriver of the pc.C.P became loose when the surgeon tried to disengage from the neck screw after insertion.We don't know if this happened while inserting the first or second lag screw.It was necessary to grip the shaft of the screwdriver with pliers to complete the operation.The components of the screwdriver were pushed back together and the device was returned reassembled".Final comments the results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The cause of the problem remains unknown.The medical evaluation evidenced as follows: "a pc.C.P operation should normally take 30 to 45 minutes.The wording is not completely clear, but as far as i can see the report states that there was a delay of at least 30 minutes.I do not think that the patient came to any significant harm, but 30 minutes is normally our threshold for a delay being significant.In this case 30 minutes is nearly 50% of the expected operating time.As this was reported grip 3 of the screwdriver of the pc.C.P became loose when the surgeon tried to disengage from the neck screw after insertion.We don't know if this happened while inserting the first or second lag screw.It was necessary to grip the shaft of the screwdriver with pliers to complete the operation.The components of the screwdriver were pushed back together and the device was returned reassembled".The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.

• Brand Name: GOTFRIED PC.C.P. NECK SCREW DRIVER
• Type of Device: GOTFRIED PC.C.P. NECK SCREW DRIVER
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9699264
• MDR Text Key: 192421293
• Report Number: 9680825-2020-00013
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: K983814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 184000
• Device Lot Number: AE1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention