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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference reports 3012447612-2021-00207 to 3012447612-2021-00210.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 that two fractured screw inserters, a deformed plug driver, and a deformed screwdriver assembly were found.They were discovered outside of surgery with no patient present.This is report four of four for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned driver was evaluated and confirmed to have a deformed tip.Potential cause this event could possibly be attributed to wear through use over time or multiple sterilization cycles.The cause of the damage cannot be determined at this time since there is no information available regarding how the screw inserter was being used or handled at the time of the damage.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use the device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that two fractured screw inserters, a deformed plug driver, and a deformed screwdriver assembly were found.They were discovered outside of surgery with no patient present.This is report four of four for this event.

• Brand Name: SCREW DRIVER
• Common Device Name: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12059496
• Report Number: 3012447612-2021-00210
• Device Sequence Number: 3869956
• Product Code: NKB
• UDI-Device Identifier: 00880304854901
• UDI-Public: (01)00880304854901(10)N27544AB
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,distri
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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 Model Number: N/A
• Device Catalogue Number: 731M0000
• Device Lot Number: N27544AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1