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

Catalog Number	5004057M0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
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 product which was not returned by the customer.Brasseler will follow up with a supplemental report if more information becomes available.
Event or Problem Description
5/64 x 5 sterile twist drill bit tip broke off mid-drill inside patient's patella during quad tendon repair.Foregin body was unable to be retrieved.

• Brand Name: KM166-10-01 5/64 X 5 STERILE TWIST DRILL
• 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: 17995660
• Report Number: 2025102-2023-00003
• Device Sequence Number: 12233330
• Product Code: HTW
• UDI-Device Identifier: 00887919448181
• UDI-Public: 00887919448181
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5004057M0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White