MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-312

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material inside the sterile packaging.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: foreign matter was mixed in the sterilization bag, so the use was postponed without opening.I want you to confirm what is going on.The root cause is a manufacturing issue.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was foreign material inside the sterile packaging.

• Brand Name: ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12838027
• MDR Text Key: 282068849
• Report Number: 0002936485-2021-00642
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613327176927
• UDI-Public: 37613327176927
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-312
• Device Lot Number: 20347AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• 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