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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the inserter broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: during a case the metal inserter of a nanotack anchor broke off the handle.The metal inserter was able to successfully be removed with artery clips and the case continued.I have the anchor with me and if needed can return to stryker for investigation - potentially there is a quality issue with our nanotack anchors.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14214817
• Report Number: 0002936485-2022-00197
• Device Sequence Number: 5195249
• Product Code: MBI
• UDI-Device Identifier: 07613327294606
• UDI-Public: 07613327294606
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: AS
• PMA/510(K) Number: K131769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 21284AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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 Age: 46 YR
• Patient Sex: Female