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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip of the inserter broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: distal tip of iconix inserter broke off when surgeon attempted to remove it from bone.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.All pieces were 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
• MDR Report Key: 11496033
• Report Number: 0002936485-2021-00146
• Device Sequence Number: 11480420
• Product Code: MBI
• UDI-Device Identifier: 37613327283465
• UDI-Public: 37613327283465
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 3910500222
• Device Lot Number: 19143AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1