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	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
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 inserter tip broke and remained in the patient.
Additional Manufacturer Narrative
Alleged failure: the tip of the inserter broke off within the bone and remained in the bone.It seems that the tip was caught in any tissue at the start of the strike, poor progress was made at the start of insertion.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 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.
Event or Problem Description
It was reported that the inserter tip broke and remained in the patient.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15095249
• Report Number: 0002936485-2022-00424
• Device Sequence Number: 14769399
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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