MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3505-6545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
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.Reference reports: 3012447612-2020-00586 and 3012447612-2020-00587.
Event or Problem Description
It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report one of two.
Additional Manufacturer Narrative
The complaint is unrefuted for two (2) of two (2) path finder nxt implant (part number 3505-6545) for the reported failure of broken screw.Medical records were not provided for review.Device evaluation: the products were not returned and no photos, intra-op/post-op images, or surgical notes were provided, so an evaluation is unable to be performed.The complaint is non-verifiable for the reported failure of broken screw.Complaint history search: a complaint history search was performed.Dhr review and related actions per dhr review, the parts were 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 devices are used for treatment.Potential cause this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.
Event or Problem Description
It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report one of two.
Additional Manufacturer Narrative
Added information to d3: email address, d8 corrected information in d4: lot number, unique identifier (udi) number, h4 this follow-up report is being submitted to relay additional information and initially corrected information.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report one of two.
Event or Problem Description
It was reported that two pathfinder nxt screws fractured in-situ when tightening the nut.The two screws were removed and replaced.There were no patient impacts.This is report one of two.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the tulip has disassembled from both of the returned screws.Device use: this devices are used for treatment.Potential cause: this event could possibly be attributed to off-axis forces capable of overcoming the material properties applied during impaction.With the given information, the definitive cause cannot be determined.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 45MM
• Common Device Name: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: jessica buzbee ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3038034523
• MDR Report Key: 10701618
• Report Number: 3012447612-2020-00586
• Device Sequence Number: 16937540
• Product Code: NKB
• UDI-Device Identifier: 00889024335707
• UDI-Public: (01)00889024335707(10)AAO
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2022

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: AAQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 05/06/2021; 04/29/2022
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/21/2020; 05/26/2021; 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown