MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other,user report with the FDA on 2020-03-28 for TBD UNKNOWN manufactured by Smith & Nephew, Inc..
[186538469]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2020-00021 |
| MDR Report Key | 9894743 |
| Report Source | FOREIGN,LITERATURE,OTHER,USER |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TBD |
| Generic Name | ARTHROSCOPE |
| Product Code | HRX |
| Date Received | 2020-03-28 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-28 |