MAUDE Adverse Event Report: LIFE SPINE SENTRY; SCREWDRIVER

Catalog Number	161-103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the provided images, it is likely that the root cause of the failure was that the applied torsional force or combination of torsional and bending stresses exceeded the mechanical strength of the subject device, resulting in the t-25 distal tip to fracture.This excessive torsional force may have been contributed to by several factors, including the patient's dense bone quality, inserting the screw without a pilot hole or tapping, or a combination of these factors.
Event or Problem Description
It was stated that, "the part broke as the doctor was using it to tighten a screw when installing the plate.I couldn't see inside the patient when it happened but i did see him attempt to tighten the screw and heard a snap as the driver tip broke.".

• Brand Name: SENTRY
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 25511586
• Report Number: 3004499989-2026-00027
• Device Sequence Number: 21459071
• Product Code: KWQ
• UDI-Device Identifier: 00190837034207
• UDI-Public: (01)00190837034207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180166
• 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): 06/15/2026

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: 161-103
• Device Lot Number: CNW25031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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: 66 YR
• Patient Sex: Male