MAUDE Adverse Event Report: LINCOTEK MEDICAL LLC VERSIPASS NEEDLE; PASSERNEEDLE

Model Number	4727
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint was reported from stryker involving the versipass needle manufactured by lincotek medical llc.The event took place in the united states.During a surgical procedure on (b)(6) 2026, two versipass needles fractured during use.The first needle fractured approximately halfway down the shaft during deployment.A second needle was subsequently opened and used; however, this needle fractured at the distal tip in two locations resulting in broken needle fragments becoming dislodged into the patient's meniscus.X-rays were utilized to identify and locate the retained needle fragments.Approximately one hour of additional surgical time was required to locate and retrieve the broken needle pieces from the patient.Due to the presence of retained fragments and the efforts required for retrieval the planned meniscus repair procedure could not be completed as intended.Instead, a partial lateral meniscectomy was performed in order to remove the needle fragments along with the affected meniscal tissue.The event resulted in patient involvement, medical intervention, and a surgical delay.Photographs of the broken needles and x-rays were provided with the complaint.
Additional Manufacturer Narrative
Since the device was not returned to the manufacturer (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 had to be removed by performing a lateral meniscectomy.

• Brand Name: VERSIPASS NEEDLE
• Common Device Name: PASSERNEEDLE
• Manufacturer (Section D): LINCOTEK MEDICAL LLC; 811 northwoods blvd; vandalia OH 45377
• Manufacturer (Section G): LINCOTEK MEDICAL LLC; 811 northwoods blvd; vandalia OH 45377
• Manufacturer Contact: surabhi bindiganavile seshadri ; 811 northwoods blvd; vandalia, OH 45377
• MDR Report Key: 25427387
• Report Number: 3010039400-2026-00003
• Device Sequence Number: 16023473
• 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): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 05/27/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown