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

Model Number 200-271 14/11 MM

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Event Description

Deep brain stimulator procedure.First burr hole on the left side of head bottom of green piece of attachment twisted off in 2 pieces at point of attachment in the drill.The side towards the patient remained intact.

• Brand Name: DISPOSABLE CRANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA-CUT INC; 989 main st; acton MA 01720
• MDR Report Key: 15300371
• MDR Text Key: 298674961
• Report Number: 15300371
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200-271 14/11 MM
• Device Catalogue Number: 200-271 DGR-0
• Device Lot Number: 10211
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female