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

Model Number	CAT01858
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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 procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: nanotack 1.4 flex anchors not following path of drill, in turn there was bending of the anchors.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) guide out of specification, 2) pathology such as schlerotic bone that may thicken the cortical layer.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Note: the investigation was previously closed based on findings from pi 3259938; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: nanotack 1.4 flex anchors not following path of drill, in turn there was bending of one anchor and breaking of the other anchor.All pieces were retrieved.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) movement of guide out of orientation, 3) guide buried into bone.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the anchor broke during procedure.All pieces were retrieved.

• 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: 16753869
• Report Number: 0002936485-2023-00313
• Device Sequence Number: 12905706
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Model Number: CAT01858
• Device Catalogue Number: CAT01858
• Device Lot Number: 23018AE2
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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