MAUDE Adverse Event Report: STRYKER CODMAN PERFORATOR JETABLE; CRANIAL PERFORATOR

Lot Number HJ013S

Device Problem Mechanics Altered (2984)

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

Event Date 11/15/2016

Event Type  malfunction  

Event Description

Pt in operating room for brain biopsy, during surgery the device cut thru the dura, clutch didn't stop when it should have.No damage to the brain.The top of the drill went in about 3 cm further than necessary.

• Brand Name: CODMAN PERFORATOR JETABLE
• Type of Device: CRANIAL PERFORATOR
• Manufacturer (Section D): STRYKER
• MDR Report Key: 6116425
• MDR Text Key: 60750982
• Report Number: MW5066199
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2016

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: No Information
• Device Lot Number: HJ013S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 58