MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TBD; SAW, POWERED, AND ACCESSORIES

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that a synovectomy and a thermal shrinkage on the right thumb was performed by using a shaver 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 reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use review could not be conducted.Without supporting clinical/medical documents, a thorough investigation cannot be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TBD
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9894733
• MDR Text Key: 186306849
• Report Number: 1643264-2020-00178
• Device Sequence Number: 1
• Product Code: HAB
• 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,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR