MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ROD CONNECTOR ASSEMBLIES, LATERAL, OPEN, 2 SCREW 5.5 / 6.0 MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	07.02027.001
Medical Device Problem Code	Fracture (1260)
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 one 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.
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 two of the rod connectors (pn 07.02027.001 lot p141400 and pn 07.02033.001 lot p141976) are fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied on the implant during surgery.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.
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 one of six for this event.

• Brand Name: ROD CONNECTOR ASSEMBLIES, LATERAL, OPEN, 2 SCREW 5.5 / 6.0 MM
• Common Device Name: VITALITY SPINAL FIXATION 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: 16362866
• Report Number: 3012447612-2023-00031
• Device Sequence Number: 17984593
• Product Code: NKB
• UDI-Device Identifier: 00889024007383
• UDI-Public: (01)00889024007383(10)P141400
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150896
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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: 07.02027.001
• Device Lot Number: P141400
• 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: 12/11/2015
• 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