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 Nonstandard Device (1420); Insufficient Information (3190)

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

Event Date 10/28/2021

Event Type  Injury  

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 the planned meniscus repair was aborted and the surgeon opted for a meniscectomy.

Event Description

It was reported that the planned meniscus repair was aborted and the surgeon opted for a meniscectomy.

Manufacturer Narrative

The device manufacturer date is not known.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: premature cutting of suture.Probable root cause: design: device opening for suture too large (knot slips through).Inadequate material selection for cutter (distal or proximal features).Distal assembly of cutter susceptible to fragmentation.Inadequate handle spring force.Process: inadequate assembly of device.Inadequate deburring/edge break on non-cutting surfaces.Device not manufactured to specification.Application: lack of due care when inserting device into soft tissue.Excessive force.The reported failure mode will be monitored for future re-occurrence.H3 other text: 81.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12857922
• MDR Text Key: 281131634
• Report Number: 0002936485-2021-00661
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327364699
• UDI-Public: 07613327364699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4721
• Device Catalogue Number: 4721
• Device Lot Number: 006442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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