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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
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 during the procedure the surgeon wanted to revise the screw to change the trajectory.The screw was removed using the removal tool, but then broke after it was removed from the body.An alternate screw of the same size was used to complete the case.There were no reported patient impacts.
Additional Manufacturer Narrative
Corrected information in d10 and h3.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information).The complaint is unconfirmed for one (1) of one (1) path finder nxt implant (part number 3505-6545) for the failure of fracture, but confirmed for the failure of disassembly.Device evaluation: the item returned matches the item in the complaint.Upon visual inspection the tulip head was detached from the screw.The complaint is confirmed.Complaint history search: a complaint history search was performed.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.Potential cause with the given information, the definitive cause cannot be determined.Typically, the cause is attributed to locking the closure top into place with the pedicle screw and rod, then subsequent loosening of the closure top for adjustment.The splines deform during locking in order to lock the tulip into position and prevent it from moving about the screw shaft in situ.The deformation on the splines also prevents the screw from being reused, as it allows the tulip to disassemble from the shaft once the closure top is loosened or removed.
Event or Problem Description
It was reported that during the procedure the surgeon wanted to revise the screw to change the trajectory.The screw was removed using the removal tool, but then broke after it was removed from the body.An alternate screw of the same size was used to complete the case.There were no reported patient impacts.

• 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: 10681545
• Report Number: 3012447612-2020-00573
• Device Sequence Number: 16286532
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 3505-6545
• Device Lot Number: AAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1