MAUDE Adverse Event Report: ORTHOFIX SRL TRUELOK EVO RX STRUT LONG WITH DYNA STERILE

Catalog Number	99-886005
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records orthofix srl checked the internal records related to the controls made on the device lot b2867634 (marked on component 8860053) before the market release.No anomalies have been found.The original lot, manufactured in 2023 was comprised of 51 devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation the devices involved in this event have not been received by orthofix srl yet.The technical evaluation will be performed as soon as the devices become available.
Event or Problem Description
It was reported that the tlevo long struts with dyna broke above dynamizer and patient needed to have a removal surgery.Date of removal is unknown.Breakage was realized in a follow up appointment on (b)(6) 2024.Date of removal has been requested.Please reference mfr reports 2183449-2024-00002 and 2183449-2024-00003.
Additional Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device lot b2867634 (marked on component 8860053) before the market release.No anomalies have been found.The original lot, manufactured in 2023 was comprised of (b)(6) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received from this specific device lot.Technical evaluation the results of the technical evaluation concluded that the returned devices were originally conforming to specifications.Unfortunately, the evidence collected were not sufficient to determine the root cause of the failure occurred.
Event or Problem Description
It was reported that the tlevo long struts with dyna broke above dynamizer and patient needed to have a removal surgery.Date of removal is unknown.Breakage was realized in a follow up appointment on (b)(6) 2024.The frame was completely removed as the patient was near the end of treatment.There was not an additional frame applied to the patient.There still seems to be a non union present but the patient is diabetic and did not take great care of themselves.Otherwise patient is well.Please refernece mfr reports 2183449-2024-00002 and 2183449-2024-00003.

• Brand Name: TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
• Common Device Name: TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, it ; IT
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, it ; IT
• Manufacturer Contact: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona, it ; IT
• MDR Report Key: 19313049
• Report Number: 2183449-2024-00004
• Device Sequence Number: 7010510
• Product Code: KTT
• UDI-Device Identifier: 18052469472071
• UDI-Public: 18052469472071
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K212044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 99-886005
• Device Lot Number: B2867634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female