MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 2 WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE F; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-522
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Implant Pain (4561)
Date of Event	07/02/2020
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 there was a need for a revision surgery.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: revision surgery.Probable root cause: design.Poor anchor assembly design.Instrumentation not designed to insert anchor to proper depth process.Anchor not manufactured to specification.Anchor coating process out of specification.Instrumentation manufactured out of specification application.User does not tension anchor properly.Insufficient force used to tension repair (knots not tight enough).Too much bone removed/decorticated.Insufficient quality or quantity of bone that would compromise secure anchor fixation.Pathology such as schlerotic bone that may thicken the cortical layer.Bone necrosis during drilling.H3 other text : 81.
Event or Problem Description
It was reported that there was a need for a revision surgery.

• Brand Name: ICONIX 2 WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE F
• 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: 10336207
• Report Number: 0002936485-2020-00319
• Device Sequence Number: 16938522
• Product Code: MBI
• UDI-Device Identifier: 37613252450345
• UDI-Public: 37613252450345
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 3910-500-522
• Device Lot Number: 19010AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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
• Patient Age: 26 YR