MAUDE Adverse Event Report: Stryker Endoscopy-San Jose FG CINCHLOCK SS ANCHOR WITH INSERTER; fastener, fixation, nondegradable, soft tissue

Catalog Number	CAT02462
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that for the involved cinchlock ss anchor.After anchor insertion, while tensioning the tape, the tape physically broke through the side of the anchor.The suture itself remained intact, but the anchor failed.After these failures, the surgeon made the decision to abandon the labral repair and instead debride and remove the patient¿s labrum.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: FG CINCHLOCK SS ANCHOR WITH 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25565571
• Report Number: 0002936485-2026-00395
• Device Sequence Number: 10249719
• Product Code: MBI
• UDI-Device Identifier: 07613252633228
• UDI-Public: (01)07613252633228(17)270119(10)25202AE2
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Catalogue Number: CAT02462
• Device Lot Number: 25202AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: Other
• Patient Sex: Unknown