MAUDE Adverse Event Report: ORTHOFIX SRL MONOBLOC REAMER D. 8.5 MM L. 475 MM

Catalog Number 172085

Device Problem Mechanical Problem (1384)

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

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

Technical evaluation: the involved device was received on (b)(6) 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: product code: 172085 (monobloc reamer d.8.5 mm l.475 mm).Batch number: 9003760001.Quantity: 1.Hospital name: (b)(6).Surgeon's name: dr (b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient's information: (b)(6) years, male.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: "(b)(6) year-old patient treated for osteosynthesis by centromedullary nailing.When using mobile olive reamers, a reamer broken in the patient's tibial bones.The olive remained at the bottom of the was tibial when the reamer was removed.The olive has been recovered".Event reported by the hospital involved to ansm (report ref: (b)(4) dated (b)(6) 2020).The complaint report form also indicated: the device failure did not have any adverse effects on patient.The initial surgery was not completed with the device.A replacement device was immediately available to complete the surgery.The event led to a delay in the duration of the surgical procedure (total delay is unknown; other effects: infection risk).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 not available.Product is available for return.Patient current health conditions: no direct consequence for the patient.Note and comments: infection risk increased by an extension of time operating, handling additional boxes.Manufacturer ref: (b)(4).Distributor ref: (b)(4).

Manufacturer Narrative

Technical evaluation the device involved, received on february 11, 2020, was sent to orthofix srl quality engineering department for the technical evaluation.The returned device was subjected to visual check as per orthofix specification.The visual check confirmed the problem notified: the end part of the device is broken.The device was then sent to the supplier for the failure analysis.The results of the technical evaluation confirmed that the device was originally conforming to orthofix specification.The breakage occurred is attributable to end of life from repeated intended use as it has experienced approximately eight (8) years of use.Medical evaluation the information made available on the event together with the results of the technical evaluation was sent to our medical evaluator.Please find below an extract of the medical evaluations performed."in this case a 16 year old male patient was having an intramedullary nail inserted into a tibia because of a fracture.The surgeon was using an 8.5 mm diameter monoblock reamer.The reamer is used to enlarge the intramedullary cavity to allow for the insertion of a large enough diameter nail to support the bone until healing.On this occasion the reamer broke, exactly where was not specified.All of the fragments were retrieved and the olive apparently had to be retrieved separately and this was done.There was an unspecified delay; another reaming set was produced and the operation was completed as planned.Reamers are reused all the time.They are expensive and designed for this work.It is usually impossible to see when a reamer is near the end of its useful life because they look just the same.This was a small diameter 8.5 mm reamer head.The tibia in a 16 year old patient may be very narrow.Reamers do break unexpectedly, but not very frequently.The important thing is to discard a reamer head if it becomes blunt, to use all sizes of reamer head in the correct ascending order, and to advance the reamer steadily without too much pressure.A broken reamer head may still happen in spite of best practice, and it is one of the known risks of inserting an intramedullary nail.The cause of the failure of this reamer is attributed to repeated normal use and final wear and tear".Final comments the results of the technical evaluation confirmed that the device was originally conforming to orthofix specification.The breakage occurred is attributable to end of life from repeated intended use as it has experienced approximately eight (8) years of use.A complete medical evaluation was not performed as some information about the medical procedure and x-rays have not been made available.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: - product code: 172085 (monobloc reamer d.8.5 mm l.475 mm) - batch number: 9003760001 - 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: tibia - surgery description: fracture treatment - patient's information: 16 years, male - problem observed during: clinical use on patient/intraoperative - type of problem: device functional problem - event description: "16-year-old patient treated for osteosynthesis by centromedullary nailing.When using mobile olive reamers, a reamer broken in the patient's tibial bones.The olive remained at the bottom of the was tibial when the reamer was removed.The olive has been recovered".- event reported by the hospital involved to ansm (report ref: aa 2020/0039 dated (b)(6)2020).The complaint report form also indicated: - the device failure did not have any adverse effects on patient - the initial surgery was not completed with the device - a replacement device was immediately available to complete the surgery - the event led to a delay in the duration of the surgical procedure (total delay is unknown; other effects: infection risk) - 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 not available - product is available for return - patient current health conditions: no direct consequence for the patient - note and comments: infection risk increased by an extension of time operating, handling additional boxes manufacturer ref: (b)(4).Distributor ref: cf 11.

• Brand Name: MONOBLOC REAMER D. 8.5 MM L. 475 MM
• Type of Device: MONOBLOC REAMER D. 8.5 MM L. 475 MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9731410
• MDR Text Key: 190333719
• Report Number: 9680825-2020-00020
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 172085
• Device Lot Number: 9003760001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR