MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number	3572-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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 surgeon complained that two t-handle torque ratcheting handles did not apply enough torque intra-operatively.The surgery was able to be completed using the same tool with greater force, and there no patient impact; however, there was a 10 minute delay on surgery.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number, serial number, & udi number, and h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report: 3012447612-2024-00228.
Event or Problem Description
It was reported that a surgeon complained that two t-handle torque ratcheting handles did not apply enough torque intra-operatively.The surgery was able to be completed using the same tool with greater force, and there no patient impact; however, there was a 10 minute delay on surgery.This is report one of two for this event.
Event or Problem Description
It was reported that a surgeon complained that two t-handle torque ratcheting handles did not apply enough torque intra-operatively.The surgery was able to be completed using the same tool with greater force, and there no patient impact; however, there was a 10 minute delay on surgery.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.A torque test was performed with eq-1919 a/b cal.Due 3/24/2026.Per drawing 3572-1 rev.C the torque output should be 90 in-lbs +/- 4.5in-lbs.The handle had consistent readings that are within specification.The average reading was 92.4 in-lbs.Root cause: a definitive root cause cannot be determined with the information provided.No device problem was found.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS
• 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20020634
• Report Number: 3012447612-2024-00227
• Device Sequence Number: 21001344
• Product Code: NKB
• UDI-Device Identifier: 00889024336513
• UDI-Public: (01)00889024336513(10)643089-024
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132884
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2025

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: 3572-1
• Device Lot Number: 643089-024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/17/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic