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 two of five for this event.
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 two of five for this event.
Additional Manufacturer Narrative
Correction in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the set screws on the connectors have minor damage/gouges.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the parts were likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• 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: 12158194
• Report Number: 3012447612-2021-00239
• Device Sequence Number: 14398421
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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
• 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: 06/16/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female