MAUDE Adverse Event Report: BRADSHAW MEDICAL INC. FORTRESS PEDICULAR FIXATION; FINAL DRIVER

Model Number	64-04-01
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device found it to be within specification.Unit measured 8.92-9.20 nm (specification range 8.5-11.5 nm).No actions were taken.This is a belated report for a medical device related event that was reported on june 16, 2016.This is a belated report for a medical device related event that occurred on june 16, 2016.At the time, our company (bradshaw medical inc.) was not fully aware of specific requirements for mdr reporting.We are submitting this report now to ensure completed transparency and compliance with fda regulations.Since this incident, we have implemented improved procedures to ensure timely reporting of all mdr even.
Event or Problem Description
An mdr report was not submitted within 30 days of receiving or otherwise becoming aware of information below that reasonably suggests that a marketed device had malfunctioned and required intervention to prevent permanent damage.Specifically, bradshaw medical inc.Failed to submit an mdr report within 30 days for an event reported to bradshaw medical which fortress final driver orthopedic surgical device part no 64-04-01 fda a class i device was used in spine surgery where set screw became loose and required a revision surgery to tighten screw.This is a belated report for a medical device related event that bradshaw medical inc.Became aware of on 16jun2016 and is documented in company's complaints (b)(4) (same event).At the time, our company (bradshaw medical inc.) was not fully aware of the specific requirements for mdr reporting.We are submitting this report now to ensure complete transparency and compliance with fda regulations.Since this incident, we have implemented procedures to ensure timely reporting of all mdr events.During a 2017 fda observation, it was noted that a late mdr was necessary.However, during feb 2022 fda inspection, it was observed that the mdr was not issued.The fda form 483 indicated that bradshaw failed to report the mdr due to a lack of resources.At that time, we were unsure if it was acceptable to submit a late mdr.However, we have since confirmed that mdrs must be reported even if they are late.As a corrective action, we have implemented a process to ensure timely mdr submissions in the future.

• Brand Name: FORTRESS PEDICULAR FIXATION
• Common Device Name: FINAL DRIVER
• Manufacturer (Section D): BRADSHAW MEDICAL INC.; 10325 58th place; kenosha WI 53144
• Manufacturer (Section G): BRADSHAW MEDICAL INC.; 10325 58th place; kenosha WI 53144
• Manufacturer Contact: tania shammo ; 10325 58th place; kenosha, WI 53144 ; 2622886450
• MDR Report Key: 19650344
• Report Number: 3006846753-2024-00001
• Device Sequence Number: 15073889
• Product Code: LXH
• UDI-Device Identifier: M7406410017
• UDI-Public: M7406410017
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Exemption Number: EXEMPT
• 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
• Remedial Action: Inspection
• Type of Report: Initial

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: 64-04-01
• Device Catalogue Number: 641-0017
• Device Lot Number: BR14024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown