MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for TRAY ELITE PRMIUM II SHLDR ARTHRO SYS 72202042 manufactured by Smith & Nephew, Inc..
[140437969]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140437970]
It was reported that the drill broke inside the femoral tunnel. Fragments were totally removed. It is unknown if there was delay or if a back up device was used. Procedure was successfully completed. No patient injury or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2019-00041 |
| MDR Report Key | 8462388 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2015-01-04 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | 0 |
| Brand Name | TRAY ELITE PRMIUM II SHLDR ARTHRO SYS |
| Generic Name | STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES |
| Product Code | KCT |
| Date Received | 2019-03-28 |
| Catalog Number | 72202042 |
| Lot Number | 14990002 |
| 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 | 2019-03-28 |