MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCESSORIES,ARTHROSCOPIC

Model Number 72202468

Device Problem Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, after t1 of the fast-fix 360 was implanted, t2 was deployed simultaneously.The procedure was completed without significant surgical delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information in d4 (expiration date) & h4.Corrected information in d1, d2, d4 (catalog number & udi number).

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H10 h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual evaluation of the device shows it was not returned in the original packaging.The t2 and a small part of the suture are at the tip of the needle.The t1 was not returned.The actuator is in the pre-t1/post-t2 position.There is bio debris on the needle and handle.A functional evaluation of the device showed the device cycled as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: ACCESSORIES,ARTHROSCOPIC
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14983419
• MDR Text Key: 295671849
• Report Number: 1219602-2022-00994
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554023169
• UDI-Public: 00885554023169
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2022

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 Expiration Date: 04/08/2024
• Device Model Number: 72202468
• Device Catalogue Number: 72202674
• Device Lot Number: 2075934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/08/2022; 10/21/2022; 12/12/2022
• Supplement Dates FDA Received: 07/20/2022; 11/04/2022; 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Female