MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW DRIVER, STANDARD; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02054.001

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

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 report 3012447612-2022-00011 through 3012447612-2022-00012.

Event Description

It was reported the tips of three screwdrivers were found to be stripped during a routine inspection.The specific surgical information is unknown.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.Inspection: the returned devices were examined.Visual inspection revealed that each device had a warped/twisted tip.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or excessive torque applied to the drivers.Device usage: 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 the tips of three screwdrivers were found to be stripped during a routine inspection.The specific surgical information is unknown.This is report one of three for this event.

• Brand Name: SCREW DRIVER, STANDARD
• 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: 13258984
• MDR Text Key: 284113481
• Report Number: 3012447612-2022-00010
• Device Sequence Number: 1
• Product Code: NKB
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02054.001
• Device Lot Number: AA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1