MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR; TORQUE LIMITING HANDLE

Model Number	PC2-200014
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the pc2-200014 torque limiting handle has been returned and is currently being evaluated.A supplemental report will be submitted once the investigation has been completed.Possible adverse events: bending, disassembly, or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.Intraoperative warnings: if the construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.
Event or Problem Description
During a surgery that took place on (b)(6) 2026, the northstar torque limiting handle bound during use.The distributor representative reported that there was no backup instrument available, therefore, the surgeon had to proceed with manual tightening and could not confirm whether the final construct was tightened to the specified torque.Although no patient injury was reported, the inability to verify that the construct was tightened to the validated torque specification may compromise construct stability post-operatively.Based on this risk and the potential for patient harm, the event was determined to be reportable.
Additional Manufacturer Narrative
Investigation conclusion: the returned pc2-200014 torque limiting handle was visually inspected to verify the failure mode described in the complaint.Examination of the instrument showed that the tab on the torque handle could not be retracted and was completely seized.It was also determined that there was evidence of impaction on the surface of the torque-limiting handle's retractable collar.As a result, the reported failure mode was confirmed during the investigation.Root cause: successful application of tensile force to the retractable collar was sufficient to release the jam.Based on the root cause analysis, it was concluded that the failure mode was likely caused by improper use of the torque-limiting handle in the field.

• Brand Name: NORTHSTAR
• Common Device Name: TORQUE LIMITING HANDLE
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad, CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 24369358
• Report Number: 3012120772-2026-00002
• Device Sequence Number: 4914166
• Product Code: LXH
• UDI-Device Identifier: 10889981199579
• UDI-Public: 10889981199579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PC2-200014
• Device Catalogue Number: PC2-200014
• Device Lot Number: AL704334C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown