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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10681545
• MDR Text Key: 211921700
• Report Number: 3012447612-2020-00573
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)AAL
• Combination Product (y/n): N
• PMA/PMN Number: K132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1