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	11/13/2024
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
Alleged failure: anchor was malleted in, deployed, and had to be removed forcefully.The inserter rod remained in the center of the implant and detached from the handle.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: 20908412
• Report Number: 0002936485-2024-00944
• Device Sequence Number: 15603223
• Product Code: MBI
• UDI-Device Identifier: 07613327123661
• UDI-Public: 07613327123661
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/21/2025

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: 24061AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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