MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-12 for SPIDER2 SHOULDER STABILIZATION KIT 72203833 manufactured by Smith & Nephew, Inc..
[179440837]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[179440838]
It was reported that, during a shoulder arthroscopy, while using the spider limb positioner, surgical site arm kept falling down while attached to limb positioner. At times during use when surgical assist would touch anywhere on green wire connector cord, not just the button, the arm would fall. Surgical assist kept holding arm for safety. The procedure was successfully completed without delay using the same device. No patient injury or other complications were reported. 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 | 3003604053-2020-00006 |
| MDR Report Key | 9697524 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| 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 | SPIDER2 SHOULDER STABILIZATION KIT |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2020-02-12 |
| Catalog Number | 72203833 |
| Lot Number | 20190320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-12 |