MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG CINCHLOCK FLEX KNOTLESS ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CAT02643
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
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 the pull wire remained in the anchor.The pull wire was able to be removed.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.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: pull wire remaining in the anchor.Probable root cause: application: - user unfamiliarity with device.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the pull wire remained in the anchor.The pull wire was able to be removed.
Additional Manufacturer Narrative
The product has now been physically received at stryker endoscopy, usa.Investigation as follows is now based on product received.Alleged failure: when the anchor was released, the wire broke and remained in the anchor (cat02643, lot24240ae2).The wire could be removed from the patient.The failure(s) identified in the investigation is consistent with the complaint record.The root cause was due to a supplier manufacturing change from hoosier to sle peek components that resulted in a performance shift.Testing and comparative analysis between sle and hoosier components revealed higher seating forces for the sle components, which is consistent with the pull wire breakages in the field.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the pull wire remained in the anchor.The pull wire was able to be removed.

• Brand Name: FG CINCHLOCK FLEX KNOTLESS 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: 21484619
• Report Number: 0002936485-2025-00151
• Device Sequence Number: 8547168
• Product Code: MBI
• UDI-Device Identifier: 07613327123661
• UDI-Public: 07613327123661
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151314
• 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,Followup
• Report Date (Section B): 06/17/2025

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: CAT02643
• Device Lot Number: 24240AE2
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/16/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 06/12/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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