MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE F; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-512

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided once the investigation has been completed.

Event Description

It was reported after the use of an all suture iconix anchor an mri scan indicated a metal like substance in the anchor space.

Manufacturer Narrative

Gtin: (b)(4).The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: signal came up on the mri scan indicating a metal like substance in the anchor space.Probable root cause: design; guide mouth or shaft too weak, guide shaft material weak, guide windows too large.Process; guide manufactured out of specification.Application; excessive force on guide.

Event Description

It was reported after the use of an all suture iconix anchor an mri scan indicated a metal like substance in the anchor space.

• Brand Name: ICONIX 1 WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE F
• Type of Device: 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: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7162358
• MDR Text Key: 96317075
• Report Number: 0002936485-2018-00001
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K133671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-512
• Device Lot Number: 17069AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other