MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 14MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number REF 26-1221

Device Problem Protective Measures Problem (3015)

Patient Problem Brain Injury (2219)

Event Date 03/31/2021

Event Type  Injury  

Event Description

During a deep brain stimulator case, during the use of the perforator, a perforator used for the procedure didn't stop (even though design was supposed to stop drilling after penetration) and caused a dural and cortical tear.Per doctor there was no permanent long term damage to the patient.The device was sent to the company for examination.

• Brand Name: CODMAN DISPOSABLE PERFORATOR 14MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11831205
• MDR Text Key: 250833492
• Report Number: 11831205
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 26-1221
• Device Catalogue Number: REF 26-1221
• Device Lot Number: J74X88
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other