MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-472

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Fungal Infection (2419)

Event Date 06/11/2021

Event Type  Injury  

Event Description

It was reported that the patient had an infection requiring an additional procedure.

Manufacturer Narrative

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

Event Description

It was reported that the patient had an infection requiring an additional procedure.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: infection.Probable root cause: design: sterilization cycle not capable of reducing bioburden at worst-case locations.Device design not able to be sterilized.Device packaging does not retain sterile barrier.Process: error in packaging or sterilization process.Application use past device/packaging shelf life.User contaminates device.Rough handling of sterile packaging.Use of expired product.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16382390
• MDR Text Key: 309614816
• Report Number: 0002936485-2023-00126
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-472
• Device Lot Number: 21056AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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