MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-322
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2019
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 unintended material was left in the joint.
Event or Problem Description
It was reported that unintended material was left in the joint.
Additional Manufacturer Narrative
The case was completed: labrum in the hip was replaces with the anchors, but two small metal parts are still in the patients body.There was a delay of 30 minutes.The surgeon did not try to get the broken tip out as it war deep in the hip with the iconix anchor.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on inserter or 2) movement of guide out of orientation to pilot hole.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: ICONIX 2 TT 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: 8593064
• Report Number: 0002936485-2019-00197
• Device Sequence Number: 19242118
• Product Code: MBI
• UDI-Device Identifier: 37613327176934
• UDI-Public: 37613327176934
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/13/2019

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: 3910-500-322
• Device Lot Number: 18031AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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