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
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.
Event or Problem Description
It was reported that the nanotack guide was placed on the acetabular rim.A nanotack drill was successfully used to create pilot hole without and problems.Anchor was introduced to guide and malleted into bone.Trigger arms on anchor were deployed, and guide was pulled from joint.Upon the removal of the nanotack guide multiple peek fragments of the nanotack flex anchor were protruding from acetabular rim.Majority of anchor remained in the bone but about 30% of anchor body fragmented into the joint.These pieces were removed from the joint space.

• 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: 22956868
• Report Number: 0002936485-2025-00757
• Device Sequence Number: 8530338
• 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