MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG., NANOTACK TT SUTURE ANCHOR, 1.4MM WITH 1.2MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CAT02969
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The manufacture date is not known at this time.However, should it become available it will be provided in future reports.
Additional Manufacturer Narrative
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 split in half.Probable root cause: design, inserter/implant not compatible with guide, inserter material/design too weak, inserter shaft cannot bend around curved guide, guide mouth not designed to grip bone, guide not able to be gripped tightly, clearance between anchor coupling and inserter id too large, inserter tube wall thickness too thin.Process: inserter, implant, and/or guide manufactured out of spec, anchor not assembled properly to inserter.Application: excessive force impacting inserter, movement of guide out of orientation, guide buried into bone.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.

• Brand Name: FG., NANOTACK TT SUTURE ANCHOR, 1.4MM WITH 1.2MM XBRAID TT
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18803789
• Report Number: 0002936485-2024-00176
• Device Sequence Number: 7295305
• Product Code: MBI
• UDI-Device Identifier: 07613327294606
• UDI-Public: 07613327294606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/16/2024

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: CAT02969
• Device Lot Number: 23298AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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