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

Model Number	CAT02969
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
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 broke during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: anchor broken.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 product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.H3 other text: 81.

• 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
• MDR Report Key: 11408096
• Report Number: 0002936485-2021-00123
• Device Sequence Number: 19380854
• Product Code: MBI
• UDI-Device Identifier: 07613327294606
• UDI-Public: 07613327294606
• 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): 05/04/2021

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 Model Number: CAT02969
• Device Catalogue Number: CAT02969
• Device Lot Number: 20195AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2021
• Supplement Date Received by Manufacturer: 02/06/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1