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

Catalog Number	137M0003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that the tip of of a cage inserter shaft broke off intra-operatively.The tip was recovered from the patient and discarded; there were no impacts to the patient.
Event or Problem Description
It was reported that the tip of of a cage inserter shaft broke off intra-operatively.The tip was recovered from the patient and discarded; there were no impacts to the patient.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h4 and h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed a portion of the threaded tip has fractured off.Additionally, the impact knob is loose on the shaft.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive forces applied to the tip during use and wear through use over time.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ZYSTON STRUT STANDARD INSERTER INNER SHAFT
• Common Device Name: ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20416674
• Report Number: 3012447612-2024-00265
• Device Sequence Number: 12835994
• Product Code: MAX
• UDI-Device Identifier: 00880304856875
• UDI-Public: (01)00880304856875(10)984801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171495
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 137M0003
• Device Lot Number: 984801
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic