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

Model Number 26-1221

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Laceration(s) (1946)

Event Date 07/18/2019

Event Type  malfunction  

Event Description

The patient underwent a craniotomy for evacuation of subdural hematoma due to trauma.The surgeon was utilizing a 14 mm drill bit, the drill bit "plunged" and became lodged inside the skull.An attempt was made to remove the pieces, however, the pieces separated.Using a high-speed electric drill and an m8 drill bit, the craniostomy was widened circumferentially and the drill bit was removed.The dura was lacerated but the brain was noted to be uninjured underneath.The procedure was completed with no further complications or known patient injury.

• Brand Name: CODMAN
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8864182
• MDR Text Key: 153382456
• Report Number: 8864182
• 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: 07/26/2019,07/23/2019

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: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: J3024U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA