MAUDE Adverse Event Report: BRADSHAW MEDICAL FIREBIRD SFS; TORQUE LIMITING HANDLE

Model Number	52-1512
Medical Device Problem Codes	Calibration Problem (2890); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device did not return for investigation.If the device is returned an investigation will be performed and a follow up report will be submitted.
Event or Problem Description
It was reported the instrument was defective.There was a delay in the case by 30-minutes.No additional information was provided.

• Brand Name: FIREBIRD SFS
• Common Device Name: TORQUE LIMITING HANDLE
• Manufacturer (Section D): BRADSHAW MEDICAL; 10325 58th place; kenosha WI 53144
• Manufacturer (Section G): BRADSHAW MEDICAL; 10325 58th place; kenosha WI 53144
• Manufacturer Contact: nick hack
• MDR Report Key: 25191907
• Report Number: 2183449-2026-00028
• Device Sequence Number: 10385294
• Product Code: LXH
• UDI-Device Identifier: 18257200047437
• UDI-Public: 18257200047437
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 52-1512
• Device Lot Number: 35269NK22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2017
• 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 Sex: Unknown