MAUDE Adverse Event Report: ORTHOFIX SRL TITANIUM ANKLE HINDFOOT NAIL 10/200

Model Number 99-T77020

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t77020 lot b1047979 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation: the device involved in this event has not been received by orthofix (b)(4).The technical evaluation of the event 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 failure investigation are available.As soon as further information is 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 initially provided by the local distributor indicates: hospital name: (b)(6) hospital.Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2017.Body part to which device was applied: hind foot.Surgery description: n/a.Patient information: unknown.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: per tm- the ankle hindfoot nail, 99-t77020, b1047979 broke in half.The case that was done at (b)(6) on (b)(6) 2017 with dr.(b)(6).Tm advised that she will not be able to get the nail back.The complaint was reported to the tm during the later part of (b)(6).The complaint report form also indicates: the device failure had adverse effects on patient.The surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required following device failure: date of the revision surgery not confirmed yet.A medical intervention (outpatient clinic) was not required.Copies of the operative report and x-ray images are not available.Patient current health conditions: unavailable.(b)(4).

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t77020 lot b1047979 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation a technical evaluation of the device concerned was not performed as the device was not returned.Medical evaluation the information made available on the event was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.In this patient the nail was inserted on (b)(6) 2017.It was reported that the nail had 'broken in half' at the end of (b)(6) 2018.That is 16 months later.If the bone round the nail has not healed, so that the nail continues to bear all of the bending and axial loads, eventually the nail will reach the end of its fatigue life and will break.This would not have happened if the bone had healed as originally intended.We know nothing about the individual case except for the fact that the nail broke after 16 months.You have asked for more information will might help explain the details of the implant, but for now this is all we have.It is very highly likely that this nail failed because of fatigue failure because the implant had been subjected to repeated high value weightbearing bending loads over a long period, more than one year.The breakage could probably have been prevented by recognition of non union of the bone and the taking of steps to encourage bony union.The nail failed because it was subjected to bending loads beyond its design criteria.Further information has been requested for us to understand the exact circumstances of this breakage.Final comments: a technical evaluation of the device concerned was not performed as the device was not returned.The technical evaluation will be performed as soon as the device become available.A complete medical evaluation of the case was not performed as no information about the medical procedure, and x-rays have been made available.Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.Should further information and/or the device involved is provided, orthofix (b)(4) will promptly re-open the case and finalize the investigation.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).

Event Description

The information initially provided by the local distributor indicates: hospital name: (b)(6) hospital.Surgeon name: dr.(b)(6).Date of initial surgery: (b)(6) 2017.Body part to which device was applied: hind foot.Surgery description: n/a.Patient information: unknown.Problem observed during: into treatment/post-operative.Type of problem: device functional problem event description: per tm- the ankle hindfoot nail, 99-t77020 b1047979 broke in half.The case that was done at (b)(6) medical on (b)(6) 2017 with dr.(b)(6).Tm advised that she will not be able to get the nail back.The complaint was reported to the tm during the later part of (b)(6).The complaint report form also indicates: the device failure had adverse effects on patient.The surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required following device failure: date of the revision surgery not confirmed yet.A medical intervention (outpatient clinic) was not required.Copies of the operative report and x-ray images are not available.Patient current health conditions: unavailable.Note: the rep does not have any further information regarding this complaint.(b)(4).

• Brand Name: TITANIUM ANKLE HINDFOOT NAIL 10/200
• Type of Device: TITANIUM ANKLE HINDFOOT NAIL 10/200
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 8124835
• MDR Text Key: 129053102
• Report Number: 9680825-2018-00098
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 18054242512882
• UDI-Public: (01)18054242512882(11)161109(17)211009(10)B1047979
• Combination Product (y/n): N
• PMA/PMN Number: K141571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 99-T77020
• Device Catalogue Number: 99-T77020
• Device Lot Number: B1047979
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention