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

Model Number 26-1221

Device Problem Mechanical Jam (2983)

Patient Problem Laceration(s) (1946)

Event Date 06/15/2019

Event Type  malfunction  

Event Description

The perforator did not stop when drilling and got stuck in the skull.The instrument was tested before using and it was working fine.We had to drill the perforating drill bit out using an acorn and am-8 drill bit.We proceeded to make the rest of the perforations with an acorn drill bit and the perforating drill bit was removed in its entirety.The dura was lacerated, however, no underlying injury was observed.

• 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: 8863902
• MDR Text Key: 153367703
• Report Number: 8863902
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• 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
• Device Lot Number: J14G99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA