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 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 3012447612-2021-00441.

Event Description

It was reported the tips of two screw drivers were found to be stripped during a routine inspection.No patient or surgical information in available.This is report one of two for this event.

Manufacturer Narrative

Device evaluation: despite very minimal cosmetic damage, functional testing on the vitality screwdrivers revealed that their threads were unable to properly mate with the tulip head of the screw (tested using part 07.02020.075 lot t09180).Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr reviews, the parts were likely conforming when they left zimvie control.Device use these devices are 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 two screw drivers were found to be stripped during a routine inspection.No patient or surgical information in available.This is report one of two 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: 12888394
• MDR Text Key: 281577652
• Report Number: 3012447612-2021-00440
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024009806
• UDI-Public: (01)00889024009806(10)AA36
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: AA36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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