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	Foreign Body In Patient (2687)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the anchor broke during the procedure and had to wait 30 mins for replacement.One (1) faulty anchor was unable to be removed and left inside the patient.
Event or Problem Description
It was reported that the anchor broke during the procedure and had to wait 30 mins for replacement.One (1) faulty anchor was unable to be removed and left inside the patient.
Additional Manufacturer Narrative
It was confirmed the device is not available for investigation in-house.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: anchor broke probable root cause: application - excessive force impacting inserter - extremely hard bone, no pilot hole drilled - poor patient bone quality the reported 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: 21862202
• Report Number: 0002936485-2025-00360
• Device Sequence Number: 7916945
• 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: Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CAT02462
• Device Lot Number: 24288AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 75 KG