MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CNNLTD 5.5 PLYSCRW 6.5X45; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3505-6545
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
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.
Event or Problem Description
It was reported that after final tightening was completed, the surgeon decided to change the trajectory of the screw and removed the screw.Once the pathfinder nxt screw was removed after final tightening, the head unlocked from the shaft.There was no adverse event.There was no reported patient impact.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device evaluation: the product was not returned for evaluation.However, photos were provided which reveal that the head screw disassembled from the screw shank.The complaint is confirmed.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the screw was being used or handled at the time of the damage.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.A follow-up report will be submitted if new information is received that changes the information provided in this report.Device use this device is used for treatment.
Event or Problem Description
It was reported that after final tightening was completed, the surgeon decided to change the trajectory of the screw and removed the screw.Once the pathfinder nxt screw was removed after final tightening, the head unlocked from the shaft.There was no adverse event.There was no reported patient impact.

• Brand Name: CNNLTD 5.5 PLYSCRW 6.5X45
• 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: 10483610
• Report Number: 3012447612-2020-00506
• Device Sequence Number: 14301483
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)AAL
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 3505-6545
• Device Lot Number: AAL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1