MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG. NANOTACK SUTURE ANCHOR 1.4MM W FLEX INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CAT01858
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon deployment of the anchor and removal of the guide, the peek portion of the nanotack anchor were protruding from the joint.The fragmented pieces were pulled from the joint and the suture portion pulled out of the leftover anchor and out of the joint space.
Additional Manufacturer Narrative
It was confirmed the device is not available for evaluation in-house as the device remained partially implanted in the patient.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: anchor breaking.Probable root cause: process: inserter, implant, and/or guide manufactured out of spec.Anchor not assembled properly to inserter application.Excessive force impacting inserter.Movement of guide out of orientation.Guide buried into bone.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: FG. NANOTACK SUTURE ANCHOR 1.4MM W FLEX INSERTER
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22956858
• Report Number: 0002936485-2025-00758
• Device Sequence Number: 8529887
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: CAT01858
• Device Lot Number: 25056AE2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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