MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for STRAIGHT SCREWDRIVER 71362293 manufactured by Smith & Nephew, Inc..
[67807963]
Patient Sequence No: 1, Text Type: N, H10
[67807964]
The screwdrivers and screw were all stripped while trying to remove the acetabular screw, therefore, both screwdriver shafts were replaced and the screw was removed utilizing a midas-rex burr. The surgery time was extended more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[77953511]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2017-00110 |
| MDR Report Key | 6342677 |
| Date Received | 2017-02-20 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2001-09-15 |
| Date Added to Maude | 2017-02-20 |
| 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 | MRS CLAUDIA DE SANTIS |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer Phone | 0628320660 |
| 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 | STRAIGHT SCREWDRIVER |
| Generic Name | SCREWDRIVER, SURGICAL |
| Product Code | LRZ |
| Date Received | 2017-02-20 |
| Model Number | 71362293 |
| Catalog Number | 71362293 |
| Lot Number | 01JM06391 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2017-02-20 |