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 Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the customer reported that after removing the inserter from the hole in the humeral arm head, the surgeon noticed that a part of metal end holding the anchor is missing.The anchor was not implanted and the missing part of inserter remained in the patient's body.There was no adverse consequences to the patient, another device was used and the surgery was completed sucesfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Visual inspection: tip breakage observed.Bent distal end observed as well.The probable root causes for the reported failure involving this device could be due to excessive force applied by user to device or inserter and pilot hole misaligned during impaction.Manufacture date is not known.(b)(4).

Event Description

It was reported that the customer reported that after removing the inserter from the hole in the humeral arm head, the surgeon noticed that a part of metal end holding the anchor is missing.The anchor was not implanted and the missing part of inserter remained in the patient's body.There was no adverse consequences to the patient, another device was used and the surgery was completed successfully.

• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5464746
• MDR Text Key: 39200051
• Report Number: 0002936485-2016-00217
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K133671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• 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: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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