MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; INSERTER

Model Number	86-0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer changed to "yes".Investigation conclusion: the returned inserter instrument was visually inspected to confirm the failure mode outlined in the description of the complaint.After reviewing the instrument, it was confirmed that the tip of the inner draw rod sheared off from the component.The location of the break occurred right at the point where the inner draw rod is exposed past the outer sleeve locating tips.Another observation found during the visual inspection was that the draw rod experienced more resistance than normal while moving through the internal threaded region of the sleeve.Upon further review, it was determined that the bottom thread start was partially deformed.Also, it should be noted that the returned inserter was marked as 86-0010, but the returned inner draw rod component was 86-0011-20.86-0011-20 in the inner draw rod intended for the inserter version that includes a depth stop.Root cause: the reported complaint may be due to misuse, surgical technique, or excessive torsional force.These devices are part of loaner sets that are subject to handling and repeat use after distribution.Wear and damage can occur over time.Exact root cause unable to be determined.Review of labeling: intraoperative warnings breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Additional Manufacturer Narrative
H3: instrument has been returned, but outcome of the investigation is still pending.Review of labeling: intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Event or Problem Description
The surgeon reported the tip of the shoreline acs inserter broke while performing surgery on (b)(6) 2024.The distal tip of the inserter was left in the patient.Customer confirms there was no patient injury, no delay in surgery and the surgery was completed successfully.The issue did not require additional medical or surgical treatment.

• Brand Name: SHORELINE ACS
• Common Device Name: INSERTER
• 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: 21127982
• Report Number: 3012120772-2025-00003
• Device Sequence Number: 17888137
• Product Code: MAX
• UDI-Device Identifier: 10889981126889
• UDI-Public: 10889981126889
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K240830
• 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): 02/25/2025

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: 86-0010
• Device Catalogue Number: 86-0010
• Device Lot Number: AL652047G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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