MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 3.5MM X 16MM CC TRANSLATING SCREW; NEXTGEN ALTIUS OCT SYSTEM

Catalog Number 14-524216

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 06/15/2020

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 3012447612-2020-00336.

Event Description

It was reported that during the procedure the threads of the tulip heads of two screws were damaged while the gun reducer was being used.All the material was removed from the patient and the damaged screws were removed and replaced with alternates to complete the case.There was no reported patient harm.This is event two of two for this event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6: not implanted.D7: not explanted.D11: catalog#: 14-524216 lineum 3.5mm x 16mm cc screw lot#: ni.The event is confirmed with photographs received.Visual examination of the provided pictures identified the two screws had fractured.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5MM X 16MM CC TRANSLATING SCREW
• Type of Device: NEXTGEN ALTIUS OCT SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10242360
• MDR Text Key: 198088664
• Report Number: 3012447612-2020-00337
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K113593
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-524216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1