MAUDE Adverse Event Report: STRYKER INSTRUMENTS ZYPHR DISPOSABLE CRANIAL PERFORATOR LARGE 41/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number 5100-060-001

Device Problem Mechanical Problem (1384)

Patient Problem Tissue Damage (2104)

Event Date 04/08/2020

Event Type  malfunction  

Event Description

Clutch didn't engage properly, and the perforator perforated deeper than it should have.Fda safety report id #: (b)(4).

• Brand Name: ZYPHR DISPOSABLE CRANIAL PERFORATOR LARGE 41/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI 49001
• MDR Report Key: 9982579
• MDR Text Key: 188685346
• Report Number: MW5094201
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 5100-060-001
• Device Lot Number: 20057017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR