MAUDE Adverse Event Report: LINCOTEK MEDICAL VERSIPASS NEEDLE; PASSERNEEDLE

Model Number	4727
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned to the manufufacturer (lincotek medical), the investigation was mainly performed on the the dhr.The assembly level lot # is 1007830 and the packaging level lot # is 1008625.There were no issues identified during the dhr review.The ifu for the device clearly specifies "use of excessive force to grasp tissue may cause intrument breakage or patient injury".The user may have used excessive force in this case but the cause is unknown.This complaint was considered reportable as a fragment of the needle remained in the patient's body.
Event or Problem Description
Lincotek medical was notified by stryker on 04/08/2026 of a needle breakage event that occurred at the surgical site.During a meniscus root repair procedure using the veripass suture passer and needle, two needle tips fractured within the patient.One fragment was successfully retrieved, while the other remained embedded in the meniscal tissue at the site of breakage.The issue was identified during the procedure, which was completed successfully without any reported delay.However, the adverse outcome was that one needle tip remained in the patient's meniscus.

• Brand Name: VERSIPASS NEEDLE
• Common Device Name: PASSERNEEDLE
• Manufacturer (Section D): LINCOTEK MEDICAL; 811 northwoods blvd; vandalia OH 45377
• Manufacturer (Section G): LINCOTEK MEDICAL; 811 northwoods blvd; vandalia 45377
• Manufacturer Contact: surabhi bindiganavile seshadri ; 811 northwoods blvd; vandalia, OH 45377
• MDR Report Key: 24972039
• Report Number: 3010039400-2026-00002
• Device Sequence Number: 17356006
• Product Code: GAB
• UDI-Device Identifier: 00860794002679
• UDI-Public: 00860794002679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4727
• Device Catalogue Number: 4727
• Device Lot Number: 1008625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown