MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TBD ARTHROSCOPE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that a synovectomy on the right thumb was performed by using a vulcan radio-frequency ablation probe to treat mcpj volar plate instability. The patient had its thumb hyperextensibility resolved. However, it was complicated with rupture of the fpl tendon. The patient complained of inability to flex the thumb interphalangeal joint while trying to catch an object at 23 days after the operation. Flexor tendon repair was performed under general anesthesia. The mcpj remained stable and was held by the fibrotic volar plate. The operation technique was modified with a1 pulley release and fpl protection. This patient demonstrated a good hand function in subsequent follow up and she had the mcpj stability maintained at the 11th year after the operation. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3,h6: the device, which was used in a procedure, was not returned for evaluation. Visual inspection and functional testing could not be performed. A relationship, if any, between the device and the reported incident could not be confirmed. A review of the manufacturing records could not be performed because the part number and lot number were not provided. Without supporting clinical/medical documents, a thorough investigation cannot be performed. There are no factors that are known to contribute to the alleged fault/failure.

• Brand Name: TBD
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9894743
• Report Number: 3003604053-2020-00021
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K003893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 21 YR
• Patient Outcome(s): Other