MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02030.001

Device Problem Material Deformation (2976)

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

Event Date 04/28/2022

Event Type  malfunction  

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 3012447612-2022-00147 through 3012447612-2022-00149.

Event Description

It was reported that three vitality connectors stripped intra-operatively; the screw driver kept turning with all three.They were each removed and replaced with a fourth connector to complete the procedure without patient impacts.This is report one of three for this event.

Manufacturer Narrative

Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no signs of damage.A functional inspection was performed with a set screw starter (07.02119.001 lot 102938) and found that the two connectors with lot number p141383 have one screw that continuously turns while the other end does tighten as expected.Neither screw on the connector with lot number w724491 tighten.Potential cause: root cause was unable to be determined.This event could possibly be attributed to the screws being turned through getting stuck or cross-threaded.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: 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 Description

It was reported that three vitality connectors stripped intra-operatively; the screw driver kept turning with all three.They were each removed and replaced with a fourth connector to complete the procedure without patient impacts.This is report one of three for this event.

• Brand Name: ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD
• 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: 14465185
• MDR Text Key: 292500000
• Report Number: 3012447612-2022-00147
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024007444
• UDI-Public: (01)00889024007444(10)P141383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02030.001
• Device Lot Number: P141383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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
• Patient Sex: Female