MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW DRIVER ASSY; VITALITY SPINAL FIXATION SYSTEM, VITALITY®+ POWER INSTRUMENT SYSTEM

Catalog Number	731M0000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported a driver was found with a deformed tip during a routine inspection.It is unknown when the tip became deformed.
Event or Problem Description
It was reported a driver was found with a deformed tip during a routine inspection.It is unknown when the tip became deformed.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation - visual and functional inspection revealed that the screwdriver tip does mate properly with the screw head, however the threads on the driver are stripped and will not engage the tulip head of a mating screw.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 review, the part was likely conforming when it left zimmer biomet 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.

• Brand Name: SCREW DRIVER ASSY
• Common Device Name: VITALITY SPINAL FIXATION SYSTEM, VITALITY®+ POWER INSTRUMENT 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: 12824299
• Report Number: 3012447612-2021-00428
• Device Sequence Number: 4335488
• Product Code: NKB
• UDI-Device Identifier: 00880304854901
• UDI-Public: (01)00880304854901(10)N27544AB
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 731M0000
• Device Lot Number: N27544AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown