MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED 5.5 POLYAXIAL SCREW 6.5X40; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3505-6540
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.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.Reference reports: 3012447612-2020-00591 to 3012447612-2020-00594.
Event or Problem Description
Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report three of four for this event.
Event or Problem Description
Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report three of four for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information: h3, h6 (methods, results, conclusions).The complaint is unconfirmed for one path finder nxt screw for the reported failure of stripped during implantation but confirmed for disassembled tulip head.Visual inspection reveals the screw is deformed with the shaft being disconnected from the tulip.The complaint is confirmed for disassembled and unconfirmed for striped threads.The device was likely conforming when it left zimmer biomet's control.Currently, no action is recommended.

• Brand Name: CANNULATED 5.5 POLYAXIAL SCREW 6.5X40
• Common Device Name: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10785907
• Report Number: 3012447612-2020-00593
• Device Sequence Number: 4089582
• Product Code: NKB
• UDI-Device Identifier: 00889024335691
• UDI-Public: (01)00889024335691(10)88MW
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 3505-6540
• Device Lot Number: 88MW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1