MAUDE Adverse Event Report: LIFE SPINE INC. SOLSTICE; DRILL

Catalog Number	2014-0006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event, it is likely that the cause of the failure mode was an excessive torsional load placed on the device which exceeded the mechanical strength of the drill/tap.This load was likely contributed to by dense patient bone and/or the application of the load at an off-axis angle from the embedded portion of the tap.
Event or Problem Description
It was stated that, "i am not sure how the drills broke.The broken tips were removed using a needle driver.There didn't seem to be any adverse effects to the patient.".

• Brand Name: SOLSTICE
• Common Device Name: DRILL
• Manufacturer (Section D): LIFE SPINE INC.; 13951 s quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 23976826
• Report Number: 3004499989-2026-00001
• Device Sequence Number: 4565857
• Product Code: KWP
• UDI-Device Identifier: 00190837040208
• UDI-Public: (01)00190837040208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200896
• 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): 01/06/2026

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 Catalogue Number: 2014-0006
• Device Lot Number: CNW24071 & CNW25031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 20 YR
• Patient Sex: Female