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
Event or Problem Description
It was stated that, "the tip of the t25 inserter broke while advancing alif plate screw.".
Additional Manufacturer Narrative
Based on the returned device, 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 tip and inner shaft shearing off.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 a combination of these factors.

• 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: 25443630
• Report Number: 3004499989-2026-00024
• Device Sequence Number: 17574658
• 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): 06/09/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 63 YR
• Patient Sex: Male