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..
[186537920]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2020-00020 |
| MDR Report Key | 9894734 |
| 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 |