MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. FIXED TRANSVERSE CONNECTOR ASSEMBLIES 23 X 5.5MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02048.002

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that the set screw of a vitality transverse connector stripped during final tightening intra-operatively.It was removed and another transverse connector was used to complete the procedure.There were no reported patient impacts.

Manufacturer Narrative

(b)(6).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Manufacturer Narrative

Corrections in d4: udi number.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation product was not returned and photos were not provided.A device evaluation could not be performed.The complaint is unrefuted.Potential cause root cause was unable to be determined.This event could possibly be attributed to cross threading or off-axis forces applied during use of the threads.Dhr review per dhr review, the part was likely conforming when it left zimvie 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.

Event Description

It was reported that the set screw of a vitality transverse connector stripped during final tightening intra-operatively.It was removed and another transverse connector was used to complete the procedure.There were no reported patient impacts.

• Brand Name: FIXED TRANSVERSE CONNECTOR ASSEMBLIES 23 X 5.5MM
• Type of Device: 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: 14137458
• MDR Text Key: 289468736
• Report Number: 3012447612-2022-00104
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024009165
• UDI-Public: (01)00889024009165(10)P142102
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02048.002
• Device Lot Number: P142102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1