MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG. NANOTACK SUTURE ANCHOR 1.4MM W FLEX INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CAT01858
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2025
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 after surgeon unraveled the suture on the inserter, it was noticed that the flexible inserter from the anchor had broken off distally.The surgeon pulled back on the inserter and drill guide to pull the broken implant out but a piece of the anchor inserter broke off.With the help of x-ray, the surgeon was able to retrieve the floating piece in the capsule.The surgeon was not able to retrieve the piece of metal from the inserter that was implanted into the bone, so the surgeon was able to bur down flat with the bone.
Event or Problem Description
It was reported that after surgeon unraveled the suture on the inserter; it was noticed that the flexible inserter from the anchor had broken off distally.The surgeon pulled back on the inserter and drill guide to pull the broken implant out but a piece of the anchor inserter broke off.With the help of x-ray, the surgeon was able to retrieve the floating piece in the capsule.The surgeon was not able to retrieve the piece of metal from the inserter that was implanted into the bone, so the surgeon was able to bur down flat with the bone.
Additional Manufacturer Narrative
It was confirmed that the device was discarded and will not be 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: tip breaking probable root cause: process - inserter and/or guide manufactured out of specification - inserter deployment mechanism not assembled to specification - debris left in/on the device during manufacturing application - excessive force impacting anchor the reported failure mode will be monitored for future reoccurrence.

• Brand Name: FG. NANOTACK SUTURE ANCHOR 1.4MM W FLEX 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: 22057651
• Report Number: 0002936485-2025-00457
• Device Sequence Number: 18105152
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131769
• 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): 07/15/2025

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: CAT01858
• Device Lot Number: 24289AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: Unknown