MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 WIDE X 5.5 MM ROD; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02030.002

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

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.

Event Description

It was reported during the procedure the screw on the vitality cross connector would not tighten.The device was removed and replaced with an alternate to complete the case.There were no reported patient impacts.

Event Description

It was reported during the procedure the screw on the vitality cross connector would not tighten.The device was removed and replaced with an alternate to complete the case.There were no reported patient impacts.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4, udi; h3; h4; h6 evaluation codes (methods, results, conclusions).The complaint is confirmed for 1 vitality 36-41x5.5mm adj transverse connector for the reported failure of the instrument not tightening.Medical records were not provided for review.Functional testing confirmed that the device would malfunction with the screws.However, a definitive root cause was unable to be determined.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any previous actions.No holds or recalls are associated with this part number.This device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 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
• MDR Report Key: 10681659
• MDR Text Key: 211456721
• Report Number: 3012447612-2020-00575
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 07.02030.002
• Device Lot Number: P141362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1