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

Catalog Number	137M0002
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: OUTER SHAFT, STANDARD INSERTER
• Common Device Name: ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9325288
• Report Number: 3012447612-2019-00439
• Device Sequence Number: 13550002
• Product Code: MAX
• UDI-Device Identifier: 00880304856868
• UDI-Public: (01)00880304856868(10)11672
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 137M0002
• Device Lot Number: 11672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1