MAUDE Adverse Event Report: MEDTRONIC, INC. EASYDRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number DM0010FAA

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

During craniotomy, the medtronic easydrill malfunctioned and caused an unitentional dural tear.This was immediately recognized and repaired.All disposable perforators with same lot number have been removed from the shelf and returned to purchasing.We are working with manufacturer on replacing existing easydrills.Medtronic: ref-dm0010faa, lot- 1994/21, exp- [redacted date].

• Brand Name: EASYDRILL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18418148
• MDR Text Key: 331591468
• Report Number: 18418148
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2023

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 Catalogue Number: DM0010FAA
• Device Lot Number: 1994/21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White