MAUDE Adverse Event Report: ORTHOFIX US LLC LONESTAR; IMPLANT INSERTER

Model Number	83-9003
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not returned for investigation.
Event or Problem Description
It was reported that during a two level acdf on (b)(6) 2024, while inserting the cage, the tip of the inserter broke inside the threads of the cage.It was confirmed that there was no adverse effects to the patient and surgery was completed successfully with a replacement that was inside of the tray.It was reported that there was a 40-50 minute delay in the case.Several attempts for additional information have been made with no good results.The device has not returned for investigation.When the device returns an investigation will be conducted on the device.
Additional Manufacturer Narrative
The implant inserter (pn: 83-9003, ln:227533-ac09) was returned for investigation.The implant inserter shows signs of wear included slightly faded laser markings and scratches.It can be confirmed that the threaded tip broke off the inserter.The broken threaded tip was not returned for investigation, but was safely removed during surgery, with no patient harm reported.Pre-clinical testing (10112150) of 83-9003 inserter involved impaction and removal against 58.7 lbs distraction force for 507 cycles.The op-tech mentions "if repositioning is needed, use the tamp to adjust the interbody spacer position".Per the ifu, the instrument should not be used if there is any sign of damage such as binding or bending.An analysis of failure site indicates that the threaded tip was likely subjected to cumulative permanent deformation (i.E.Bending), prior to breakage.Given the nature of the instrument's design and its interface with the implant, care should be taken when positioning and/or positioning while impacting, with respect to the amount of distraction force versus the input positioning force.Any toggle or excessive movement of the inserter relative to the movement of the implant should warrant an inspection for permanent bending of the threaded tips.This instrument was manufactured in march 2023 and the complaint originated in november 2024, indicating it was within the expected 4-year lifespan.A review of the product dhr showed that all inspections met design specifications.A review of ncmr databases did not reveal any nonconformances related to this investigation.
Event or Problem Description
It was reported that during a two level acdf on (b)(6)2024, while inserting the cage, the tip of the inserter broke inside the threads of the cage.It was confirmed that there was no adverse effects to the patient and surgery was completed successfully with a replacement that was inside of the tray.It was reported that there was a 40-50 minute delay in the case.Several attempts for additional information have been made with no good reults.The device has not returned for investigation.When the device returns an investigation will be conducted on the device.

• Brand Name: LONESTAR
• Common Device Name: IMPLANT INSERTER
• Manufacturer (Section D): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX 75056
• Manufacturer (Section G): ORTHOFIX US LLC; 3451 plano parkway; lewsiville TX 75056
• Manufacturer Contact: james stephens ; 501 mercury dr.; sunnyvale, CA 94085
• MDR Report Key: 20727907
• Report Number: 2183449-2024-00023
• Device Sequence Number: 18380050
• Product Code: LXH
• UDI-Device Identifier: 18257200086092
• UDI-Public: 18257200086092
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Model Number: 83-9003
• Device Lot Number: 227533-AC09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown