MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 2 STRANDS 2.0MM XBRAID TT SUTURE TAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-920
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
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 anchors detached and remained in the patient.
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 detached and remained in the patient.Probable root cause: design poor anchor assembly design.Instrumentation not designed to insert anchor far enough into cortex.Process anchors assembled out of specification.Instrumentation manufactured out of specification.Anchor coating process out of specification.Application too much bone removed/decorticated.Excessive force used to tension anchor.Insufficient quality or quantity of bone that would compromise secure anchor fixation.Pathology such as schlerotic bone that may thicken the cortical layer.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the anchors detached and remained in the patient.

• Brand Name: ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 2 STRANDS 2.0MM 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
• MDR Report Key: 11016061
• Report Number: 0002936485-2020-00522
• Device Sequence Number: 17267069
• Product Code: MBI
• UDI-Device Identifier: 37613327374194
• UDI-Public: 37613327374194
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 3910-500-920
• Device Lot Number: 19353AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other