MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PROVISIONAL CLOSURE TOP STARTER; SCREWDRIVER

Catalog Number	07.02068.001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
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.Reference reports 3012447612-2020-00527 to 3012447612-2020-00529.
Event or Problem Description
It was reported that during the procedure two vitality drivers were deformed and one driver fractured while trying to remove a competitors screw system.There was no further surgical information provided and no patient impacts reported.This is report two of three for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrected information in h3.Information added to e3, h4, h6: component codes, type of investigation, investigation findings, investigation conclusions the complaint is confirmed for returned vitality drivers for the failure of twisted and fractured tips due to use for removing competitive screws.Medical records were not provided for review.Device evaluation: product was returned and evaluated.The tips were found to be twisted in a direction indicating use for removing screws and fractured off.The complaint is confirmed.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 and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this 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 during the procedure two vitality drivers were deformed and one driver fractured while trying to remove a competitors screw system.There was no further surgical information provided and no patient impacts reported.This is report two of three for this event.

• Brand Name: PROVISIONAL CLOSURE TOP STARTER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10522184
• Report Number: 3012447612-2020-00528
• Device Sequence Number: 3203299
• Product Code: HXX
• UDI-Device Identifier: 00889024009929
• UDI-Public: (01)00889024009929(10)AA39
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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 Catalogue Number: 07.02068.001
• Device Lot Number: AA39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1