MAUDE Adverse Event Report: ACRA-CUT INC. ACRA-CUT INC; DISPOSABLE CRANIAL PERFORATOR

Model Number	200-271
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received alleging that the disposable cranial perforator did not stop upon breakthrough during a neurosurgical procedure.The user reported continued rotation of the perforator after penetration of the cranial bone.No patient injury, adverse clinical outcome, or additional medical intervention was reported.The device was returned for evaluation.Visual inspection, dimensional inspection and functional testing were performed in accordance with established procedures.The device met all acceptance criteria and functioned as intended.The alleged malfunction could not be confirmed during the investigation.The root cause could not be determined based on the information available.Although no patient injury occurred and the reported malfunction was not confirmed, this event is being submitted as a malfunction mdr because recurrence of the alleged event could potentially result in a serious injury.
Event or Problem Description
The perforator did not stop.It was the first drill hole made with the perforator.It was in the temporal lobe.The drill bit didn't stop and simply fell through the bone, perforating the dura matter and causing a contusion in the temporal lobe.The hospital reported no death or serious injury has occured due to this event.

• Brand Name: ACRA-CUT INC
• Common Device Name: DISPOSABLE CRANIAL PERFORATOR
• Manufacturer (Section D): ACRA-CUT INC.; 989 main street; acton MA 01720
• Manufacturer (Section G): ACRA-CUT INC.; 989 main street; acton MA 01720
• Manufacturer Contact: siva manjith jangam vibhuti ; 989 main street; acton, MA 01720
• MDR Report Key: 25598579
• Report Number: 1220724-2026-05052
• Device Sequence Number: 9972003
• Product Code: HBF
• UDI-Device Identifier: 00810607000071
• UDI-Public: 810607000071
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K032970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 200-271
• Device Lot Number: 10109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown