MAUDE Adverse Event Report: LIFE SPINE INC. SOLSTICE; ROD CUTTER

Model Number	117-778
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event, it is likely that the cause of the failure mode was material fatigue and wear, leading to the progressive degradation of the devices distal blade.The instrument has been subjected to repeated high loading during use since its release which has likely contributed to cumulative stress at the distal tip of the instrument, eventually resulting in the observed fracture.The device also features rust propagation indicating the instrument was likely left wet following sterilization for an extended duration which likely contributed to the compromise of the distal tip.Complainant reported no patient impact, however, it is reasonable to assume medical or surgical intervention was required to remove the fractured components from the body cavity.Therefore, this mdr is being submitted out of an abundance of caution.
Event or Problem Description
It was stated that, "they were cutting a rod in situ, and a sliver of the cutting edge came apart.".

• Brand Name: SOLSTICE
• Common Device Name: ROD CUTTER
• Manufacturer (Section D): LIFE SPINE INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22378443
• Report Number: 3004499989-2025-00016
• Device Sequence Number: 15791426
• Product Code: KWP
• UDI-Device Identifier: 00190837039103
• UDI-Public: (01)00190837039103(10)CNW20051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 117-778
• Device Lot Number: CNW20051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female