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
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the inserter tip broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: when the subject conix self-punching was hit into the bone, the tip of the subject product was broken.There was no residual inside the body.Please investigate the cause.Reporter's request: please strengthen the strength of the product.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force or 2) pathology such as schlerotic bone that may thicken/harden the cortical layer.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the inserter tip broke during the procedure.All pieces were retrieved.

• 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
• MDR Report Key: 11737211
• Report Number: 0002936485-2021-00226
• Device Sequence Number: 14336517
• Product Code: MBI
• UDI-Device Identifier: 37613327374224
• UDI-Public: 37613327374224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Catalogue Number: 3910-500-931
• Device Lot Number: GEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1