MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION DISPOSABLE DRILL KIT; DRILLS, BURRS, TREPHINES ACCESSORIES (MANUAL)

Model Number	DDK2-2.4-30X
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of the drill broke broke during intraoperative use and remains retained in the patient, the broken piece could not be retrieved.

• Brand Name: DISPOSABLE DRILL KIT
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (MANUAL)
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORPORATION; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 25443126
• Report Number: 25443126
• Device Sequence Number: 5815324
• Product Code: HBG
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(10)0194683942943944(11)260305(17)280301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026
• Report Date (Section F): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 0194683942943944
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Date Report Sent to FDA: 06/05/2026