MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW DRIVER, STANDARD; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02054.001

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2019-00312.

Event Description

It was reported that two screw drivers would allow the mating screws to toggle when assembled together.No further information is available.This is report one of two for this event.

Event Description

It was reported that two screw drivers would allow the mating screws to toggle when assembled together.No further information is available.This is report one of two for this event.

Manufacturer Narrative

The product was not returned and no photos were provided, so an evaluation could not be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.The lot number was not provided, so the manufacturing records could not be reviewed.

• Brand Name: SCREW DRIVER, STANDARD
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8796144
• MDR Text Key: 151299370
• Report Number: 3012447612-2019-00311
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02054.001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1