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 Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor was inserted to the laserline.Upon tensioning, the suture tape broke through the anchor.After this, the surgeon pulled on the inserter to remove the implant.This was identified during the procedure when it could be seen the nitinol rod was still attached to the anchor.All pieces were removed.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the anchor was inserted to the laserline.Upon tensioning, the suture tape broke through the anchor.After this, the surgeon pulled on the inserter to remove the implant.This was identified during the procedure when it could be seen the nitinol rod was still attached to the anchor.All pieces were removed.
Additional Manufacturer Narrative
Per investigation results, the entire pull wire was still attached with no breakage.As such, this event is determined to no longer be reportable.Alleged failure: anchor was inserted to the laser line upon tensioning the suture tape broke through the anchor.After this the surgeon pulled on the inserter to remove the implant.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) incomplete lever actuation, 2) user not familiar with device use.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21913685
• Report Number: 0002936485-2025-00389
• Device Sequence Number: 7267170
• Product Code: MBI
• UDI-Device Identifier: 07613252633228
• UDI-Public: 07613252633228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/11/2025

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: CAT02462
• Device Lot Number: LOT 24282AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2025
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown