MAUDE Adverse Event Report: ORTHOFIX SRL GUIDE WIRE WITH OLIVE L980MM D2.8MM

Model Number 1

Device Problem Mechanical Problem (1384)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records.Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-183281; lot b1256628 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 60 devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device code.Technical evaluation: the technical evaluation on the returned device, received on (b)(6) 2020, is currently on going.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.

Event Description

The information provided by local distributor indicates: product code: 99-183281 (guide wire with olive l980mm d2.8mm).Batch number: b1256628.Quantity: 1.Hospital name: (b)(6).Date of initial surgery: (b)(4) 2020.Body part to which device was applied: femur.Surgery description: fracture treatment.Patient's information: no response.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "introduction of olive guide for implant of agile nail.When sorting out the guide, olive kept inside femur.It reveals impossible to extract olive without opening femur.This represents an infectious risk".The complaint report form also indicated: the device failure had adverse effects on patient (un-retrieved device fragment).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was not required.Product is available for return.No information was provided about patient current health conditions.On (b)(6) 2020, orthofix (b)(4) received the following additional information: name of the surgeon : (b)(6).Patient age and sex : birth date (b)(6), male.Copies of the pre and post-operative x-rays showing the position of the un-retrieved device fragment : request has been made internally, they should revert to us.Information about patient current health condition : ok, the consequences of the surgery are simple.On (b)(6) 2020, orthofix (b)(4) received copies of x-ray images.This incident was already notified to ansm by the hospital involved on (b)(6) 2020 (dossier: mv 20-0313).(b)(4).

Event Description

The information provided by local distributor indicates: product code: 99183281 (guide wire with olive l980mm d2.8mm), batch number: b1256628, quantity: 1, hospital 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: no response.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "introduction of olive guide for implant of agile nail.When sorting out the guide, olive kept inside femur.It reveals impossible to extract olive without opening femur.This represents an infectious risk".The complaint report form also indicated: the device failure had adverse effects on patient (unretrieved device fragment), the initial surgery was completed with the device, the event did not lead to a delay in the duration of the surgical procedure, an additional surgery was not required, product is available for return, no information was provided about patient current health conditions.On june 11, 2020, orthofix srl received the following additional information: 1).Name of the surgeon : pr franck accadbled, dr (b)(6).2).Patient age and sex : birth date (b)(6) 2004, male.3).Copies of the pre and postoperative xrays showing the position of the unretrieved device fragment : request has been made internally, they should revert to us 4).Information about patient current health condition : ok, the consequences of the surgery are simple.On (b)(6) 2020, orthofix srl received copies of xray images.This incident was already notified to ansm by the hospital involved on (b)(6) 2020 (dossier: mv 200313).Manufacturer ref: 2020086, distributor ref: cf 90.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-183281 lot b1256628 before the market release.The devices met the release specifications and no anomalies have been found.The original lot, manufactured in 2018, was comprised of 60 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 code.Technical evaluation: the returned device, received on june 24, 2020, was examined by orthofix srl quality engineering department.The wire was subjected to visual and dimensional check as per orthofix specification.The visual check confirmed the problem notified: the tip of the wire is broken.It was also evidenced presence of damaging signs on the entire external surface.The dimensional check of the wire external diameter did not evidence any anomalies.It was observed that the production option used to manufacture the wire was that of welding rather than turning from a solid wire.It was also verified the certificate of the raw material used to produce the device and it was found to be in conformity with the design specification.The returned wire was then sent to an external laboratory for the raw material verification.The results of the analysis confirmed the raw material conformity with the design specification.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."in this case from toulouse a 15 year old male patient had a femoral diaphyseal fracture.The surgeon inserted an agile nail.They say that the olive was missing from the guide wire when it was removed, and must be in the patient.Otherwise the operation was as planned.There are ap and lateral images of the inserted nail.I have the following comments: · this is a transverse simple fracture between middle and distal third of the diaphysis · there seems to be callus at the fracture site, suggesting that the fracture occurred a while ago.The surgeon has inserted 2 proximal locking screws.The operating technique is clear that only one should be inserted, i cannot see any sign of a nail end cap, the fracture position looks good.The nail was inserted on (b)(6) and the report is dated june 10th, so the callus must have formed before the nail was inserted.It is difficult to make any other comment.The patient should do well.At this age they will wish to remove the nail after healing, at which point it may be possible to remove the olive.I note also that the guide wire is showing signs of damage at the end; it may well have been this that caused the olive to detach." conclusion according to the medical evaluation, the patient should do well in these circumstances.The problem occurred is mainly attributable to a device forcing, as suggested by the signs present on the guide wire received.As our trend analysis indicated, this is an isolated event and we do not expect any repetition.However, in order to improve the device performance under all conditions of use orthofix intend to limit the production option to turning from a solid wire.Orthofix srl historical records shows that no other notifications have been received in regards to this specific device code.Orthofix continues monitoring the products on the market.

• Brand Name: GUIDE WIRE WITH OLIVE L980MM D2.8MM
• Type of Device: GUIDE WIRE WITH OLIVE L980MM D2.8MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 10216634
• MDR Text Key: 200693507
• Report Number: 9680825-2020-00038
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18054242519041
• UDI-Public: (01)18054242519041(11)180827(17)230727(10)B1256628
• Combination Product (y/n): N
• PMA/PMN Number: K172699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 1
• Device Catalogue Number: 99-183281
• Device Lot Number: B1256628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 10/01/2020
• Patient Sequence Number: 1
• Patient Age: 15 YR