MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910500222
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
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 needle separated during procedure and was potentially unable to be retrieved.
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: needle separating during the procedure.Probable root cause: design needles cannot withstand grasping by other instrumentation.Needle/suture assembly not designed to withstand manipulation and grasping.Process improper swaging of needle onto suture.Application excessive force.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the needle separated during procedure and was potentially unable to be retrieved.

• Brand Name: ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT
• 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: 16200007
• Report Number: 0002936485-2023-00044
• Device Sequence Number: 4453354
• Product Code: MBI
• UDI-Device Identifier: 37613327283465
• UDI-Public: 37613327283465
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K151201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 3910500222
• Device Lot Number: 21336AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown