MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-11 for GII PS HI FLEX ISRT TR S1-2 9 71430401 manufactured by Smith & Nephew, Inc..
[178969475]
It was reported that during a tka procedure, the trial insert cracked in half while inserting. No injuries or delays reported. A backup device was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00514 |
| MDR Report Key | 9697069 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-11 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GII PS HI FLEX ISRT TR S1-2 9 |
| Generic Name | TRAY, SURGICAL, INSTRUMENT |
| Product Code | FSM |
| Date Received | 2020-02-11 |
| Model Number | 71430401 |
| Catalog Number | 71430401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |