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	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the inserter broke during the procedure and remains imbedded in the bone.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: the tip of the inserter broke off and was buried in the bone and could not be removed.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: use of excessive force, movement of guide out of orientation to pilot hole, or use of wrong drill.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 tip of the inserter broke during the procedure and remains imbedded in the bone.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13334975
• Report Number: 0002936485-2022-00048
• Device Sequence Number: 17159832
• Product Code: MBI
• UDI-Device Identifier: 37613327283465
• UDI-Public: 37613327283465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151201
• 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): 03/08/2022

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: 3910500222
• Device Lot Number: 21222AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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