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 Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
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.
Additional Manufacturer Narrative
Please note that the initial report's type of reportable event was a malfunction for the anchor breaking.However per investigation results, there was no anchor breakage, the anchor was only bent.Therefore this event is not reportable as there was no breaking of the anchor.Alleged failure: during the surgical procedure, all the surgical technique was complied when making the tunnel with a 1.4 bit and its respective guide.After, the nano tack flex anchor was introduced with the suture threads inside the anchor and at the moment of beginning the impact it began to fracture at the tip and to bend and it was not possible to continue inserting the anchor in the hole that had been made with the drill bit and the implant was removed.Another anchorage was used and te same happened.The anchor fractured very easily with impactions with very little force.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.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.
Event or Problem Description
It was reported that the anchor broke during procedure.Please note that the initial report's type of reportable event was a malfunction for the anchor breaking.However per investigation results, there was no anchor breakage, the anchor was only bent.Therefore this event is not reportable as there was no breaking of the anchor.

• 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: 16620768
• Report Number: 0002936485-2023-00243
• Device Sequence Number: 5996527
• Product Code: MBI
• UDI-Device Identifier: 07613252633099
• UDI-Public: 07613252633099
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 21317AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• 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: 23 YR
• Patient Sex: Male