MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. NAVIGATION CANNULATED T27 BONE SCREW DRIVER; VITAL NAVIGATION SYSTEM

Catalog Number	854M0021
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two vitality connectors broke, the tip of one vitality t20 final driver broke, the tip of a vitality t27 driver twisted, and the tips of two vital navigation t27 drivers twisted intra-operatively.Other connectors and drivers were used to complete the procedure.There was a delay to the procedure that did not lead to patient impacts.This is report five of six for this event.
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.Reference reports 3012447612-2023-00031 through 3012447612-2023-00036.
Event or Problem Description
It was reported that two vitality connectors broke, the tip of one vitality t20 final driver broke, the tip of a vitality t27 driver twisted, and the tips of two vital navigation t27 drivers twisted intra-operatively.Other connectors and drivers were used to complete the procedure.There was a delay to the procedure that did not lead to patient impacts.This is report five of six for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned devices match the information in the complaint file and were examined.Visual inspection revealed the tips of two drivers (pn 854m0021 lot 312452) are twisted/deformed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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: NAVIGATION CANNULATED T27 BONE SCREW DRIVER
• Common Device Name: VITAL NAVIGATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16362884
• Report Number: 3012447612-2023-00035
• Device Sequence Number: 6756930
• Product Code: OLO
• UDI-Device Identifier: 00887868310232
• UDI-Public: (01)00887868310232(10)312452
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191722
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: Other
• Device Catalogue Number: 854M0021
• Device Lot Number: 312452
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic