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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that when the handle for the anchor deployment was squeezed, the wire that pulls the distal tip of the anchor into the main body of the anchor, snapped, and was left in the anchor.The wire remained at significant length still attached to the anchor.The surgeon had to act to remove the wire.
Additional Manufacturer Narrative
Alleged failure: when the handle for the anchor deployment was squeezed, the wire that pulls the distal tip of the anchor into the main body of the anchor, snapped, and was left in the anchor.The wire remained at significant length still attached to the anchor.The surgeon had to act to remove the wire as during regular operation of the device would have been removed once deployed.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 technique error, 3) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that when the handle for the anchor deployment was squeezed, the wire that pulls the distal tip of the anchor into the main body of the anchor, snapped, and was left in the anchor.The wire remained at significant length still attached to the anchor.The surgeon had to act to remove the wire.

• 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: 21911947
• Report Number: 0002936485-2025-00383
• Device Sequence Number: 15800409
• Product Code: MBI
• UDI-Device Identifier: 07613252633228
• UDI-Public: 07613252633228
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/15/2025

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: 24261AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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