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

Model Number 26-1221

Device Problems Entrapment of Device (1212); Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

While using the perforator to create a burr hole, when getting to the end of the burr hold creation, the perforator plunged forward and stalled.Multiple attempts were made to remove the perforator but failed.Ultimately, the surgeon used a small burr to remove the excess bone around the perforator, which then allowed the perforator to be released.Upon removal of the burr, the surgeon assessed the condition of the patient and determined no harm resulted.

• Brand Name: CODMAN
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10337527
• MDR Text Key: 200796691
• Report Number: 10337527
• 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: 07/20/2020

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: 26-1221
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA