MAUDE Adverse Event Report: BRASSELER MEDICAL, LLC KM166-310-21S QUICK CONNECT TWIST DRILL - 2.0MM DIAMETER 126.0MM TOTAL

Catalog Number	5022669M0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brasseler is reporting this alleged product malfunction in an abundance of caution.The allegations of malfunction have not been confirmed due to the inability of brasseler to perform an investigation of the twist drill which was not returned by the customer.Additionally, the customer has provided insuffient information.Brasseler has conducted a review of the data for this product and no trends have emerged.Brasseler will follow up with a supplemental report if more information becomes available.
Event or Problem Description
The majority of the drill bit was not recoverable and is still in the arm of the patient.It would have caused undue injury to remove it.No other information has been provided.

• Brand Name: KM166-310-21S QUICK CONNECT TWIST DRILL - 2.0MM DIAMETER 126.0MM TOTAL
• Common Device Name: TWIST DRILL
• 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: 20539505
• Report Number: 2025102-2024-00010
• Device Sequence Number: 12843404
• Product Code: HTW
• UDI-Device Identifier: 00887919674979
• UDI-Public: 00887919674979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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
• Device Catalogue Number: 5022669M0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown