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); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the nanotack flex anchors have been uncoiling while removing the insertion handle and reportedly causing weak points to occur.It was reported that the inserter broke upon anchor deployment and inserter was not able to be removed from patient anatomy.Reportedly surgeon was not worried about further harm.
Additional Manufacturer Narrative
According to what was reported, the device is not available for evaluation as it was discarded.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: inserter broke upon anchor deployment.Probable root cause: process: inserter and/or guide manufactured out of specification.Inserter deployment mechanism not assembled to specification.Debris left in/on the device during manufacturing.Application: excessive force impacting anchor.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the nanotack flex anchors have been uncoiling while removing the insertion handle and reportedly causing weak points to occur.It was reported that the inserter broke upon anchor deployment and inserter was not able to be removed from patient anatomy.Reportedly surgeon was not worried about further harm.

• 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: eric san miguel ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21775972
• Report Number: 0002936485-2025-00305
• Device Sequence Number: 13216825
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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 Catalogue Number: CAT01858
• Device Lot Number: 24257AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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: Other
• Patient Sex: Unknown