MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ZYSTON STRAIGHT INLINE INSERTER; ZYSTON STRAIGHT SPACER SYSTEM

Catalog Number 14-534900

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported that during the procedure the two posts on the distal end of the zyston inserter broke off.The pieces broke on the back stand and were not retained by the patient.There was no further surgical information provided and no reported patient impacts.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as the device was returned fractured.Device history record was reviewed and no discrepancies relevant to the reported event were found.As the device was manufactured in 2011, it is likely that it has undergone extensive usage, which may have caused the distal tines to weaken over time, or a large force was applied that overcame its mechanical capabilities, causing it to fracture off.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d4, d10, g4, g7, h2, h10.

Event Description

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

• Brand Name: ZYSTON STRAIGHT INLINE INSERTER
• Type of Device: ZYSTON STRAIGHT SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10440493
• MDR Text Key: 204051159
• Report Number: 3012447612-2020-00454
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K112014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-534900
• Device Lot Number: 035388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1