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

Model Number 184000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the component code 184000 lot ae1800 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4).All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the second event notified in regards to this specific device lot from the same hospital and surgeon.Technical evaluation: the involved device was received on april 14, 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 local distributor indicates: - device code: (b)(4).- batch number: ae1800.- 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) counterclockwise (as shown on page 20 operative technique) the handle loosened from the shaft.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 delay in the duration of the surgical procedure (total delay 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.- product is available for return.- 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 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, this is the second event notified in regards to this specific device lot from the same hospital and surgeon.Technical evaluation the returned device, received in assembled conditions on april 14, 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 did not evidence any anomalies.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 components of the screwdriver can be disassembled only by pushing the proper buttons.The results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The device still performs properly.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.- april 13, 2020: "in this case a patient was having a pc.C.P inserted.A part of the screwdriver handle became loose during the operation, and caused a delay of 30 minutes.Except for this the operation was as planned.We have no more information at present and must wait for the components to be returned".(b)(6) 2020 with the results of the technical evaluation: "the original story that we received was that the handle came loose from the screwdriver and it no longer functioned as specified.However, when tested at orthofix it was found that the screwdriver is functioning normally, and there is no sign of this type of malfunction.This is always unsatisfactory, because we are unable to explain how this event happened.The suggestion is that there was some local effect that caused this, as the instrument is normal".Final comments the results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The device still performs properly.The cause of the problem remains unknown.The medical evaluation evidenced as follows: "in this case a patient was having a pc.C.P inserted.A part of the screwdriver handle became loose during the operation, and caused a delay of 30 minutes.Except for this the operation was as planned.We have no more information at present and must wait for the components to be returned.The original story that we received was that the handle came loose from the screwdriver and it no longer functioned as specified.However, when tested at orthofix it was found that the screwdriver is functioning normally, and there is no sign of this type of malfunction.This is always unsatisfactory, because we are unable to explain how this event happened.The suggestion is that there was some local effect that caused this, as the instrument is normal".Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by local distributor indicates: device code: 184000 (gotfried pc.C.P.Neck screw driver).Batch number: ae1800.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) counterclockwise (as shown on page 20 operative technique) the handle loosened from the shaft.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 delay in the duration of the surgical procedure (total delay 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.Product is available for return.Patient current health conditions: good.Manufacturer ref: (b)(4).

• 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: 9980291
• MDR Text Key: 189356148
• Report Number: 9680825-2020-00033
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 18032568865752
• UDI-Public: (01)18032568865752(11)180615(10)AE1800
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 184000
• Device Catalogue Number: 184000
• Device Lot Number: AE1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention