MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE FIBER SUTURE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-922
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
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 fragmented.Probable root cause: design: nserter tips not sharp enough; inserter tips not long enough; inserter design insufficient for forces encountered during use; inserter material selection insufficient (too weak).Application: excessive force applied to inserter (g5); pathology such as schlerotic bone that may thicken/harden the cortical layer.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that when the iconixspeed was driven into the rotator cuff, the needle portion of the inserter broke off.The broken part has not been removed.The doctor decided to remain the broken part in the patient body.Procedure was completed successfully.
Event or Problem Description
It was reported that when the iconixspeed was driven into the rotator cuff, the needle portion of the inserter broke off.The broken part has not been removed.The doctor decided to remain the broken part in the patient body.Procedure was completed successfully.
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.

• Brand Name: ICONIX SELF-PUNCHING 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE FIBER SUTURE
• 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: 19282208
• Report Number: 0002936485-2024-00370
• Device Sequence Number: 12660468
• Product Code: MBI
• UDI-Device Identifier: 37613327374200
• UDI-Public: 37613327374200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 3910-500-922
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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