MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 3 STRANDS 1.2MM XBRAID TT SUTURE TAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-931
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the patient was complaining about post-operative pain.A follow-up revision surgery was performed and it was further reported that the anchors had ruptured.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: anchor pulls out of bone probable root cause: design: - poor anchor assembly design - inserter not designed to insert anchor to proper depth process: - anchor assembly not manufactured to specification - inserter not manufactured to specification application: - user does not tension anchor properly (g6) - insufficient force used to tension repair (knots not tight enough) - too much bone removed/decorticated - insufficient quality or quantity of bone that would compromise secure anchor fixation - angle of insertion varied during insertion of inserter - angle of removal varied during removal of inserter - pathology such as schlerotic bone that may thicken the cortical layer - anchors inserted too close together, weakening bone - anchor not inserted below cortical layer - anchor is caught on inserter and is pulled above cortical layer - anchor is damaged by inserter - surgeon uses drill or awl to create pilot hole; hole size incorrect - surgeon tries to reload an anchor on inserter the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient was complaining about post-operative pain.A follow-up revision surgery was performed and it was further reported that the anchors had ruptured.

• Brand Name: ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 3 STRANDS 1.2MM XBRAID TT SUTURE TAPE
• 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: 17916514
• Report Number: 0002936485-2023-01039
• Device Sequence Number: 11502401
• Product Code: MBI
• UDI-Device Identifier: 37613327374224
• UDI-Public: 37613327374224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-500-931
• Device Lot Number: 22061AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown