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

Model Number 184000

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available.As soon as the results of the investigation are 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: hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of initial surgery: n/a.Body part to which device was applied: n/a.Surgery description: fracture treatment.Patient information: n/a.Problem observed during: clinical use on patient/intraoperative.Type of problem: functional problem.Event description: the inner shaft in the driver is too long and popping out without pushing the button on top thus its impossible to assemble/disassemble it after insertion.The complaint report form also indicates: the device failure had no adverse effects on patient.The initial surgery was not completed with the device.A replacement device was immediately available to complete surgery.The event led to a clinically relevant increase in the duration of the surgical procedure: 40 minutes delay.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 condition: unknown.Further information received from the distributor on april 15, 2019: "regarding patient details, as far as i know the patient recovers and this issue didn't affect her at all.I don't have any details about her age or weight." manufacturer reference number: (b)(4).Distributor reference number: n/a.

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 184000 lot ad0528 (lot marked on component 184024) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.8 of them have already been distributed to the market.According to orthofix srl historical records this is the first complaint notified involving items of this specific lot.Technical evaluation a technical evaluation of the device involved was not possible, as it was not returned to orthofix srl.The customer confirmed that the product was discarded.Medical evaluation the information made available on the case, was sent to our medical evaluator.Please find below an extract of the medical evaluation: in this case it seems that the central shaft of the screwdriver 184000 was too long; looking at the image at the bottom of page 18 of the manual pm-pcp, this refers to the inner shaft (a) activated by grip 3.It was not possible to use the screwdriver.A second one was available but there was a delay of 40 minutes; after which the operation was completed as planned.The device in question will be inspected in due course and this will enable us to understand the details of the problem.Meanwhile for this report, the pc.C.P operation should normally take less than 30 minutes.I therefore consider that a delay of 40 minutes was clinically significant, enough to constitute a serious injury.In this case it was necessary to send out for an additional screwdriver, and presumably for it to be checked and sterilised.This might be considered an additional surgical intervention.Final comments a technical evaluation of the device concerned was not performed, as the device was not returned.A complete medical evaluation of the case was not performed as no information about the medical procedure, diagnosis and x-rays have been made available.Considering the information provided, it is not possible to draw any conclusion in regards to the complained device malfunction.The root cause remains unknown.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: - hospital name: (b)(6).- surgeon's name: dr.(b)(6).- date of initial surgery: n/a - body part to which device was applied: n/a - surgery description: fracture treatment - patient information: n/a - problem observed during: clinical use on patient/intraoperative - type of problem: functional problem - event description: the inner shaft in the driver is too long and popping out without pushing the button on top thus its impossible to assemble/disassemble it after insertion.The complaint report form also indicates: - the device failure had no adverse effects on patient - the initial surgery was not completed with the device - a replacement device was immediately available to complete surgery - the event led to a clinically relevant increase in the duration of the surgical procedure: 40 minutes delay - 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 condition: unknown further information received from the distributor on april 15, 2019: "regarding patient details, as far as i know the patient recovers and this issue didn't affect her at all.I don't have any details about her age or weight." further information received from the distributor on july 3, 2019: the screw driver was discarded.Manufacturer reference number: (b)(4).Distributor reference number: n/a.

• 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: 8526211
• MDR Text Key: 142337051
• Report Number: 9680825-2019-00025
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 184000
• Device Catalogue Number: 184000
• Device Lot Number: AD0528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention