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

Model Number 26-1221

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2019

Event Type  malfunction  

Event Description

While performing the burr hole portion of the procedure, the disposable perforator malfunctioned.After perforating the skull, the surgeon was unable to remove it from the skull.The handpiece for the perforator, as well as other equipment that adapts to the perforator were used, but still unable to remove it."we used vice grips to remove the perforator gently as our last resort method." it was removed successfully without any visible untoward effects.The handpiece was tagged to removed from service and the remaining stock of that lot number was removed from the supply area.The perforator chuck from the instrument set was returned to stryker representative.The case was discussed with the neuro coordinator and consensus was that we have never had an issue with this disposable perforator before.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9134374
• MDR Text Key: 160534518
• Report Number: 9134374
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: J1153P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA