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	Foreign Body In Patient (2687)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cinchlock flex implant failed to release the nitinol wire from the implant upon deployment.There was a small amount of the wire left in the implant which may or may not become an issue going forward.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the cinchlock flex implant failed to release the nitinol wire from the implant upon deployment.There was a small amount of the wire left in the implant which may or may not become an issue going forward.
Additional Manufacturer Narrative
Alleged failure: the doctor had 4 cinchlock flex implants fail to release the nitinol wire from the implant upon deployment.The nitinol wire was seen exiting the patient post removal of cinchlock implant inserter.4 out of 5 implants failed the same way.It was noticed by the doctor when removing the implant inserter.Additional information provided: can you please advise if there were any adverse consequences reported for the patient? there was a small amount of the wire left in the implant which may or may not become an issue going forward, we are unsure.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.

• 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: 20799352
• Report Number: 0002936485-2024-00841
• Device Sequence Number: 15142245
• Product Code: MBI
• UDI-Device Identifier: 07613327123661
• UDI-Public: 07613327123661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CAT02643
• Device Lot Number: LOT 24159AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male