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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the distal tip of the anchor inserter broke during the procedure and potentially remains in the patient.
Event or Problem Description
It was reported that the distal tip of the anchor inserter broke during the procedure and potentially remains in the patient.
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: anchor is bent/inserter broken off.Probable root cause: design.-sutures not strong enough for application process.-damage to sutures during manufacturing process application.-excessive force on sutures.The reported failure mode will be monitored for future re-occurrence.

• 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
• MDR Report Key: 9757223
• Report Number: 0002936485-2020-00081
• Device Sequence Number: 2788190
• Product Code: MBI
• UDI-Device Identifier: 37613327374200
• UDI-Public: 37613327374200
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K171465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 19010AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other