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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: anchor had to be replaced.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 sclerotic bone that may thicken the cortical layer, bone necrosis during drilling.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that a revision surgery was required because the bone around the implant had a hole about 1 cm of diameter.

• 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: 7881075
• Report Number: 0002936485-2018-00606
• Device Sequence Number: 11239820
• Product Code: MBI
• UDI-Device Identifier: 37613252450345
• UDI-Public: 37613252450345
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K133671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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: 18086AE2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/17/2018
• 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