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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL MEDIUM STRUT TL-HEX - 114MM-184MM
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ORTHOFIX SRL MEDIUM STRUT TL-HEX - 114MM-184MM Back to Search Results
Model Number 1
Device Problem Mechanical Problem (1384)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records (mfr reports 9680825-2021-00045 and 9680825-2021-00046).Orthofix srl checked the internal records related to the controls made on the device code 50-10300 batch b1452665 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of 62 units.All of them have been released to the market.Orthofix srl checked the internal records related to the controls made on the device code 50-10400 batch b1405090 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 99 units.All of them have been released to the market.(mfr 9680825-2021-00045).Orthofix srl checked the internal records related to the controls made on the device code 50-10400 batch b1406264 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 44 units.All of them have been released to the market.(mfr 9680825-2021-00046).Technical evaluation mfr reports 9680825-2021-00045 and 9680825-2021-00046).The devices involved in this event have not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the devices concerned.The technical evaluation will be performed as soon as the devices become available.Medical evaluation mfr reports 9680825-2021-00045 and 9680825-2021-00046).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 srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.
 
Event Description
The information provided by local distributor indicates: product code: 50-10300 (medium strut tl-hex - 114mm-184mm) and 50-10400 ((long strut tl-hex - 158mm-318mm) batch number: b1452665 (code 50-10300) and b1405090 (code 50-10400) and b1406264 (code 50-10400) quantity: 3 (mfr reports 9680825-2021-00045 and 9680825-2021-00046).Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: "throughout the course of the hex programme, 3 x mounting caps dislodged resulting in the mounting studs losing locking ability between the ring and the hex struts.Frame instability has experienced.".The complaint report form also indicated: the device failure had adverse effects on patient (loss of achieved correction).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.A medical intervention (outpatient clinic) was not required.Copies of the operative reports and copies of the x-ray images are not available.Product is available for return.Patient current health condition: fracture reduced and alignment acquired.Manufacturer ref: (b)(4).Please also kindly refer to mfr reports 9680825-2021-00045 and 9680825-2021-00046.
 
Event Description
The information provided by local distributor indicates: - product code: 50-10300 (medium strut tl-hex - 114mm-184mm) and 50-10400 ((long strut tl-hex - 158mm-318mm) - batch number: b1452665 (code 50-10300) and b1405090 (code 50-10400) and b1406264 (code 50-10400) - quantity: (b)(4) (mfr reports 9680825-2021-00044 and 9680825-2021-00045 and 9680825-2021-00046) - problem observed during: into treatment/post-operative - type of problem: device functional problem - event description: "throughout the course of the hex programme, 3 x mounting caps dislodged resulting in the mounting studs losing locking ability between the ring and the hex struts.Frame instability has experienced.".The complaint report form also indicated: - the device failure had adverse effects on patient (loss of achieved correction) - 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 - a medical intervention (outpatient clinic) was not required - copies of the operative reports and copies of the x-ray images are not available - product is available for return - patient current health condition: fracture reduced and alignment acquired on (b)(6), 2021, orthofix srl received the following details: - name of the hospital - (b)(6) mediclinic - name of the surgeon - dr (b)(6) - date of initial surgery - (b)(6) 2020 - date of the devices failure - (b)(6) 2021 - anatomical site - midshaft tibia - surgery description - hexapod ring fixator open mid shaft tibia - patient information (age, sex and weight) - female, 48years old - failure description: how did the components failed? - ball joint component failed on hex strut - how was managed the issue (change of strut, frame modification)? was the replacement/modification performed at the doctor office? when? - strut exchange - patient current health condition - final reduction outcome was achieved - picture of the frame realized - not available on (b)(6), 2021, orthofix srl received the following details: - the struts were exchanged at the patient's residence by dr (b)(6).Manufacturer ref: (b)(4).Please also kindly refer to mfr reports 9680825-2021-00045 and 9680825-2021-00046.
 
Manufacturer Narrative
Analysis of historical records (mfr reports 9680825-2021-00044 and 9680825-2021-00045 and 9680825-2021-00046).Orthofix srl checked the internal records related to the controls made on the device code 50-10300 batch b1452665 before the market release.No anomalies have been found.The original lot, manufactured in 2020, was comprised of 62 units.All of them have been released to the market.(mfr 9680825-2021-00044).Orthofix srl checked the internal records related to the controls made on the device code 50-10400 batch b1405090 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 99 units.All of them have been released to the market.(mfr 9680825-2021-00045).Orthofix srl checked the internal records related to the controls made on the device code 50-10400 batch b1406264 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 44 units.All of them have been released to the market.(mfr 9680825-2021-00046).Technical evaluation (mfr reports 9680825-2021-00044 and 9680825-2021-00045 and 9680825-2021-00046) the returned devices, received on june 15, 2021, were examined by orthofix srl quality operation department.The returned struts were subjected to visual and functional check as per orthofix specification.The visual check evidenced that the long strut code 50-10400, batch b1406264 (mfr 9680825-2021-00046) and the medium strut code 50-10300, batch b1452665 (mfr 9680825-2021-00044) have respectively one insert bushing and one stud diassembled.In both cases, only the stud was received, while the insert bushing was missing.The long strut code 50-10400, batch b1405090 (mfr 9680825-2021-00045) did not evidence any visual damage.The visual check evidenced presence of glue residues inside rod end joint's threaded holes of the devices batch b1406264 and batch b1452665.The visual check of the long strut code 50-10400, batch b1405090 evidenced that the insert bushing is partially unscrewed from both ends.Evident signs of usage and of chemical attack from decontamination activities are visible on all the returned struts.The functional check, performed where possible, did not evidence any anomalies.A complete functional check was not possible because the devices are damaged.Medical evaluation (mfr reports 9680825-2021-00044 and 9680825-2021-00045 and 9680825-2021-00046).The information made available on the event, together with the result of the technical evaluation, were sent to our medical consultant.Please find below an extract of the medical evaluations performed over the time: "all we know about this event is that a patient was being treated with truelok, probably for a fracture, because later the form states "fracture reduced and alignment required".3 struts failed and reduction was lost.This extra information indicates that the patient was 48 years old, female and had a mid shaft open tibial fracture; strut failure occurred about 5 weeks after application and not during initial surgery.2 rapid adjust struts were exchanged for others, not specified, and the reduction was satisfactory (suggesting that reduction was lost when they failed).It seems that the patient came to no long term harm.The problem seems to have been that insufficient glue was applied before product assembly.The technical report also notes that these struts have been used a lot and show signs of wear.In this case the struts failed possibly because in part of wear and tear".Conclusion (mfr reports 9680825-2021-00044 and 9680825-2021-00045 and 9680825-2021-00046).Orthofix failure analysis concluded that the event might have occurred due a variability in the amount of glue applied during assembly of the strut.Since the manufacture of the affected lots orthofix have implemented measures to improve the robustness of the glue application process.Orthofix srl continues monitoring the devices on the market.
 
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Brand Name
MEDIUM STRUT TL-HEX - 114MM-184MM
Type of Device
MEDIUM STRUT TL-HEX - 114MM-184MM
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, 37012
IT  37012
MDR Report Key11874908
MDR Text Key252415718
Report Number9680825-2021-00044
Device Sequence Number1
Product Code KTT
UDI-Device Identifier18054242510666
UDI-Public(01)18054242510666(11)200218(10)B1452665
Combination Product (y/n)N
PMA/PMN Number
K170650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1
Device Catalogue Number50-10300
Device Lot NumberB1452665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Date Manufacturer Received07/07/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age48 YR
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