MAUDE Adverse Event Report: ACRA-CUT INC DISPOSABLE CRANIAL PERFORATOR; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number	200-241 14/11MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in operating room for burr hole washout.When doctor attempted to drill burr hole, bit would not engage.

• Brand Name: DISPOSABLE CRANIAL PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA-CUT INC; 989 main st.; acton MA 01720
• MDR Report Key: 25081131
• Report Number: 25081131
• Device Sequence Number: 10738392
• Product Code: HBF
• UDI-Device Identifier: 00810607000019
• UDI-Public: (01)00810607000019(10)10588(17)340728
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/14/2026
• Report Date (Section F): 04/14/2026

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: 200-241 14/11MM
• Device Catalogue Number: 200-241 DGR-I
• Device Lot Number: 10588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 04/14/2026