MAUDE Adverse Event Report: ACRA-CUT, INC. DISPOSABLE CRANIAL PERFORATOR; DRILLS, BURRS, TREPHINES

Model Number 200-271 DGR-0

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

When using the acra-cut perforator to drill burr holes into the patient's cranium, the drill broke.Once the burr hole had been placed and the surgeon pulled the drill away, the perforator drill bit stayed in place and the drill pulled away.Surgeons were able to get the drill bit out and it did not appear to have caused any harm to the patient.

• Brand Name: DISPOSABLE CRANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES
• Manufacturer (Section D): ACRA-CUT, INC.; 989 main street; acton MA 01720
• MDR Report Key: 8974602
• MDR Text Key: 156911855
• Report Number: 8974602
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

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
• Device Operator: Health Professional
• Device Model Number: 200-271 DGR-0
• Device Catalogue Number: 200-271 DGR-0
• Device Lot Number: 9743
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA