MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR; LARGE 14/11MM

Model Number 5100-060-001

Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Hydrocephalus (3272)

Event Date 01/02/2014

Event Type  Injury  

Event Description

Patient had a shunt placement procedure for hydrocephalus on (b)(6) 2014.During the procedure, the surgeon reported that the burr penetrated the dura and went into the brain causing potential injury/hemorrhage.Ct performed on (b)(6) 2014 and showed a minimal peritract low attenuation hemorrhage seen within the right frontal lobe.

• Brand Name: STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR
• Type of Device: LARGE 14/11MM
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI 49001
• MDR Report Key: 3632426
• MDR Text Key: 16224701
• Report Number: 3632426
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2014

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: 5100-060-001
• Device Catalogue Number: 0043199
• Device Lot Number: 3140901132560173
• 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: 01/10/2014
• Distributor Facility Aware Date: 01/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 84