MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER; NEURO PERFORATOR

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/30/2017

Event Type  malfunction  

Event Description

The neuro perforator for the skull came off of the handle of the hand piece.Md states perforator did not act appropriately.It is supposed to go through the bone and stop, but it did not.No harm to the patient.

• Brand Name: STRYKER
• Type of Device: NEURO PERFORATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 6666615
• MDR Text Key: 78468913
• Report Number: MW5070604
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 77 YR
• Patient Weight: 112