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

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

It was reported that the anchor broke during procedure.All pieces were retrieved.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the anchor broke during procedure.All pieces were retrieved.

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: guide out of specification, 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.Manufacture date is not known.

• Brand Name: FG., NANOTACK SUTURE ANCHOR, 1.4MM W/ FLEX INSERTER
• Type of Device: 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: 16618709
• MDR Text Key: 312113792
• Report Number: 0002936485-2023-00240
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: CAT01858
• Device Catalogue Number: CAT01858
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1