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

Catalog Number	3572-1
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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 3012447612-2024-00322.
Event or Problem Description
It was reported that intra-operatively, a pathfinder torque ratchet handle was not able to tighten closure tops properly, stripping the threads on five closure tops and stripping the inner drive hexagon on three more.A pedicle screw was also reported to have disassembled during the surgery.There was no patient harm, however there was a 30 minute procedural delay as a result of this.This is report ten of ten for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number & udi number.Additional information in d4: serial 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.
Event or Problem Description
It was reported that intra-operatively, a pathfinder torque ratchet handle was not able to tighten closure tops properly, stripping the threads on five closure tops and stripping the inner drive hexagon on three more.A pedicle screw was also reported to have disassembled during the surgery.There was no patient harm, however there was a 30 minute procedural delay as a result of this.This is report ten of ten for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: 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.The torque output was tested using id:2662-b cal.Due 5/21/2026.The torque output ranged from 101.9 to 110.4 in-lbs.The performance range is 80 to 100 in-lbs.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to loss of calibration through use over time or multiple sterilization cycles causing a loss of internal lubrication.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.
Event or Problem Description
It was reported that intra-operatively, a pathfinder torque ratchet handle was not able to tighten closure tops properly, stripping the threads on five closure tops and stripping the inner drive hexagon on three more.A pedicle screw was also reported to have disassembled during the surgery.There was no patient harm, however there was a 30 minute procedural delay as a result of this.This is report ten of ten for this event.

• Brand Name: MODULAR HANDLE, T RATCHETING TLR 90 INLBS
• 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: 20737165
• Report Number: 3012447612-2024-00331
• Device Sequence Number: 20994740
• Product Code: NKB
• UDI-Device Identifier: 00889024336513
• UDI-Public: (01)00889024336513(10)86KF-012
• 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): 05/08/2025

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: 86KF-012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/27/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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 Age: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic