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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 anchor was threaded normally and placed in the hole.When tightening/adjusting the thread tension, the thread was torn out of the anchor.The anchor was therefore not triggered and was pulled out of the hole.The anchor remained in the bone; the trigger mechanism was pulled out.Further info reported: the thread was torn from the anchor.This means that either the proximal part of the anchor is broken or the thread is torn.The thread was still intact and could be used for the next anchor.We couldn't see the anchor because it was embedded in the bone.Based on our observations, i have to assume that the anchor is broken.We didn't see the anchor come out of the hole.It is possible that part of it was drilled out for the rest of the procedure (placement of additional anchors).The next step was to drill a new hole in the bone to refix the labrum with a new anchor.Estimated delay: 5 minutes.
Event or Problem Description
It was reported that the anchor was threaded normally and placed in the hole.When tightening/adjusting the thread tension, the thread was torn out of the anchor.The anchor was therefore not triggered and was pulled out of the hole.The anchor remained in the bone, the trigger mechanism was pulled out.Further info reported: the thread was torn from the anchor.This means that either the proximal part of the anchor is broken or the thread is torn.The thread was still intact and could be used for the next anchor.We couldn't see the anchor because it was embedded in the bone.Based on our observations, i have to assume that the anchor is broken.We didn't see the anchor come out of the hole.It is possible that part of it was drilled out for the rest of the procedure (placement of additional anchors).The next step was to drill a new hole in the bone to refix the labrum with a new anchor.Estimated delay: 5 minutes.
Additional Manufacturer Narrative
The device was not returned for investigation.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 breaking 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23794392
• Report Number: 0002936485-2025-00986
• Device Sequence Number: 14845462
• Product Code: MBI
• UDI-Device Identifier: 07613252633228
• UDI-Public: 07613252633228
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 25149AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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