MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

Catalog Number 22-4038

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

It was reported that, during an arthroscopic procedure, the front end of the "firstpass suture passer" did not open smartly after stitching the tissue.The medical staff needed some time and force to open the mouth to leave the joint.The device was bent during that maneuver.The procedure was successfully completed without significant delay using a back-up device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The image provided by the customer showed the device, but did not reveal any information regarding the functionality.Visual inspection of the device revealed that the needle is protruding from the distal end of the jaw.The device did not perform as intended the needle did not deploy when the lever was pressed.The complaint was verified and the root cause was determined as a manufacturing process error.The failure is being assessed for recommended actions.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10532487
• MDR Text Key: 206954349
• Report Number: 1219602-2020-01397
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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 Expiration Date: 03/19/2023
• Device Catalogue Number: 22-4038
• Device Lot Number: 2053221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR