MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED DORSAL HEIGHT REVISION TOOL; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3558-50
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2020
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 a dorsal height adjuster broke while attempting to remove a previously-implanted screw.Another screwdriver was used to complete the surgery without any reported health impacts to the patient.
Event or Problem Description
It was reported that a dorsal height adjuster broke while attempting to remove a previously implanted screw.Another screwdriver was used to complete the surgery without any reported health impacts to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed for one returned pathfinder nxt revision instrument for the failure of fracture.Medical records were not provided for review.Device evaluation: the product was returned and visually examined.The tip can be seen to have fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied to the tip during use, or wear through use over time or multiple sterilization cycles.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: CANNULATED DORSAL HEIGHT REVISION TOOL
• 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: 10795479
• Report Number: 3012447612-2020-00611
• Device Sequence Number: 2875304
• Product Code: NKB
• UDI-Device Identifier: 00889024336391
• UDI-Public: (01)00889024336391(10)62WA
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 3558-50
• Device Lot Number: 62WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1