MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKER 2-0 KNOT PUSHER/SUTURE CUTTER AND SLOTTED CANNULA SET; ACCESSORIES, ARTHROSCOPIC

Model Number 4721

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 09/24/2020

Event Type  malfunction  

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 there was foreign material inside the sterile packaging.

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: foreign material inside the sterile packaging.Probable root cause: process: uncontrolled environmental conditions.The reported failure mode will be monitored for future re-occurrence.Manufacture date is not known.

Event Description

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

• Brand Name: STRYKER 2-0 KNOT PUSHER/SUTURE CUTTER AND SLOTTED CANNULA SET
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10706178
• MDR Text Key: 213677492
• Report Number: 0002936485-2020-00425
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327364699
• UDI-Public: 07613327364699
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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 Model Number: 4721
• Device Catalogue Number: 4721
• Device Lot Number: 005415
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1