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 left thumb was performed by using a vulcan radio-frequency ablation probe to treat mcpj volar plate instability.However, this case had recurrence of thumb mcpj hyperextension noted at 10 weeks post operation which progressed to 30 degrees of hyperextension at 6 months post op.The patient complained of persistent pain and weakness at the thumb.Therefore, open volar plate capsulodesis with suture anchor was performed at 13 months after the first operation.Patient outcome is unknown.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.If the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: TBD
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9894734
• MDR Text Key: 186537920
• Report Number: 3003604053-2020-00020
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/28/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR