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 Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer 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 in the sterile packaging.

Event Description

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

Manufacturer Narrative

Alleged failure: a foreign substance was found inside the package.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be a manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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
• 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: 15496799
• MDR Text Key: 306282180
• Report Number: 0002936485-2022-00547
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327364699
• UDI-Public: 07613327364699
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 11/09/2022

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 Model Number: 4721
• Device Catalogue Number: 4721
• Device Lot Number: 007441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 11/09/2022
• 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