MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OUTER SHAFT, STANDARD INSERTER; ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM

Catalog Number 137M0002

Device Problems Fracture (1260); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 10/16/2019

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.Reference report 3012447612-2019-00438.

Event Description

It was reported that during the procedure the surgeon had difficulty removing the inserter from the implant and a part of it broke off.The inserter was removed by twisting the inner shaft with pliers until it released.No patient harm or significant surgical delay was reported.This is report two of two.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complaint is confirmed based on the provided photograph for one returned zyston outer shaft standard inserter for the failures of fracture and jammed.Medical records were not provided for review.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.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.

Event Description

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

• Brand Name: OUTER SHAFT, STANDARD INSERTER
• Type of Device: ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9325288
• MDR Text Key: 166775617
• Report Number: 3012447612-2019-00439
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00880304856868
• UDI-Public: (01)00880304856868(10)11672
• Combination Product (y/n): N
• PMA/PMN Number: K171495
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 137M0002
• Device Lot Number: 11672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1