MAUDE Adverse Event Report: BRASSELER USA KM166-10-01 STERILE TWIST DRILL 5/64 X 5"

Catalog Number	5004057M0
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1:29 pm while the attending surgeon was drilling the femur to tie the tagging stitch, the drill broke inside the patient's femur.The team was unsuccessful removing it.Approximately 1 inch was broken off in the femur.No other information was provided.
Additional Manufacturer Narrative
Brasseler is reporting this alleged event 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 device which was not returned by the customer.Brasseler will follow up with a supplemental report if more information becomes available.

• Brand Name: KM166-10-01 STERILE TWIST DRILL 5/64 X 5"
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 15052653
• Report Number: 2025102-2022-00007
• Device Sequence Number: 4772649
• Product Code: HTW
• UDI-Device Identifier: 00887919448181
• UDI-Public: (01)00887919448181(17)261208(10)NV1CN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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: 5004057M0
• Device Lot Number: NV1CN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown