MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER INSTRUMENTS; ZYPHR DISPOSABLE CRANIAL PERFORATOR

Model Number REF 5100-060-001

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 04/26/2016

Event Type  Injury  

Event Description

A (b)(6) male in the operating room for the removal of a temporal mass, during drilling of the burr holes, the drill penetrated the dura of the brain.There was no harm to the patient and the rep for the company was called.The device was given to the rep at that time.

• Brand Name: STRYKER INSTRUMENTS
• Type of Device: ZYPHR DISPOSABLE CRANIAL PERFORATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS; 6901 portage rd; portage MI 49002
• MDR Report Key: 5723149
• MDR Text Key: 47349418
• Report Number: 5723149
• 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: 05/29/2016

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: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: REF 5100-060-001
• Device Catalogue Number: 16077037
• Device Lot Number: SS3170301160770373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2016
• Distributor Facility Aware Date: 05/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 87