MAUDE Adverse Event Report: BRASSELER MEDICAL, LLC BR213524 3.2 X 110MM BONE PINS

Catalog Number	5031011M0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Pins breaking in patient.
Additional Manufacturer Narrative
Brasseler is reporting this alleged event in an abundance of caution.Details of an adverse event have not been confirmed due to unresponsiveness from the customer after numerous attempts.Brasseler is unable to perform an investigation of the broken product which was not returned by the customer.Brasseler will follow up with a supplemental report if more information becomes available.

• Brand Name: BR213524 3.2 X 110MM BONE PINS
• Common Device Name: BONE PINS
• Manufacturer (Section D): BRASSELER MEDICAL, LLC; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 22294072
• Report Number: 2025102-2025-00005
• Device Sequence Number: 8310365
• Product Code: HTY
• UDI-Device Identifier: 00887919970972
• UDI-Public: (01)00887919970972(17)290917(10)N01CM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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 Catalogue Number: 5031011M0
• Device Lot Number: N01CM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown