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

Model Number	83-9003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant inserter (pn: 83-9003 ln:214636-wb25) was returned for investigation.The implant inserter shows minimal signs of wear.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.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 the tip of the instrument was broken.The distributor reported that there was a 40-50 minute delay in the case.No further case details were provided.
Event or Problem Description
It was reported that the tip of the instrument was broken.The distributor reported that there was a 40-50 minute delay in the case.New information received 12/13/2024 this report is updates the new case information provided.
Additional Manufacturer Narrative
The implant inserter (pn: (b)(4), ln: 214636-wb25) was returned for investigation.The implant inserter shows minimal signs of wear.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 (b)(4) 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.A review of the product dhr showed that all inspections met design specifications.A review of ncmr databases did not reveal any nonconformance's related to this investigation.

• Brand Name: LONESTAR
• Common Device Name: INPLANT 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 ; 3451 plano parkway; lewisville, TX 75056
• MDR Report Key: 20917682
• Report Number: 2183449-2024-00025
• Device Sequence Number: 12038599
• Product Code: LXH
• UDI-Device Identifier: 18257200086092
• UDI-Public: 18257200086092
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 12/13/2024

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: 214636-WB25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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