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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
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.Reference reports 3012447612-2021-00238 through 3012447612-2021-00242.
Event or Problem Description
It was reported that the surgeon had difficulties with set screw tightening intra-operatively.The set screws on three cross connectors cross-threaded, the driver tip fractured, and the torque handle did not limit the torque.The driver tip was recovered, the cross-connectors were removed, and alternative cross-connectors were used to complete the procedure without reported patient impacts.This is report three of five 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
• MDR Report Key: 12158197
• Report Number: 3012447612-2021-00240
• Device Sequence Number: 3782245
• Product Code: NKB
• UDI-Device Identifier: 00889024007383
• UDI-Public: (01)00889024007383(10)P142144
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 07.02027.001
• Device Lot Number: P142144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1