MAUDE Adverse Event Report: ORTHOFIX, LLC FORZA; 9MM CURVED IMPLANT SHAFT ASSEMBLY

Model Number	89-0117
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for investigation.If the device returns, we will perform an investigation at that time.
Event or Problem Description
It was reported that during a case at (b)(6), the 89-0117 inserter tip fractured off of the inserter during cage placement.The cage was removed with and a new cage had to be replaced.This incident caused a 45-minute delay in surgery.No additional adverse effects to the patient were reported.
Additional Manufacturer Narrative
The 9mm curved implant shaft assembly (pn: 89-0117, ln: 219447-xd21) was returned and show minimal signs of wear.It was confirmed that one of the tips on the distal end had broken off.The cross-sectional area at the tip is small, so the age of the instrument paired with impacting force perpendicular to the axis of the shaft has the possibility of breaking the tip.This device was manufactured in april 2021 and the complaint originated in (b)(6) 2025, indicating it was beyond the expected 4 year lifespan.The failure is within the expected occurrence range.
Event or Problem Description
It was reported that during a case at (b)(6), the 89-0117 inserter tip fractured off of the inserter during cage placement.The cage was removed with and a new cage had to be replaced.This incident caused a 45-minute delay in surgery.No additional adverse effects to the patient were reported.

• Brand Name: FORZA
• Common Device Name: 9MM CURVED IMPLANT SHAFT ASSEMBLY
• Manufacturer (Section D): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 22322639
• Report Number: 2183449-2025-00021
• Device Sequence Number: 15658223
• Product Code: LXH
• UDI-Device Identifier: 18257200077021
• UDI-Public: 18257200077021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 89-0117
• Device Lot Number: 219447-XD21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male