MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VIRAGE T15 FINAL DRIVER; SCREWDRIVER

Catalog Number 07.01748.001

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

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 that the tip of the driver sheared off during the procedure.The tip was retrieved and an alternate device was used to complete the case.There were no reported patient impacts.

Manufacturer Narrative

The returned driver was evaluated.Visual inspection revealed that a portion of the tip has fractured off.A hardness test showed that the tip of the device has a hardness of 51.5 hrc which meets the specified minimum of 46 hrc.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.A capa was initiated for this issue previously.The root cause was determined to be that the virage final drivers cannot withstand the greater-than-expected torque that is likely being applied intraoperatively due to additional off-axis force and the increased torque range of the handle.The design was enhanced to remove the ruby ball feature and change it to a straight solid tip.The driver associated with this complaint was manufactured prior to the design enhancement.

Event Description

It was reported that the tip of the driver sheared off during the procedure.The tip was retrieved and an alternate device was used to complete the case.There were no reported patient impacts.

• Brand Name: VIRAGE T15 FINAL DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9527993
• MDR Text Key: 175241993
• Report Number: 3012447612-2019-00568
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/19/2020

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: 07.01748.001
• Device Lot Number: 62594498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1