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 2018-05-22 for CONQUEST FN SCREWDRIVER 71179215 manufactured by Smith & Nephew, Inc..
[108849302]
Patient Sequence No: 1, Text Type: N, H10
[108849303]
It was reported that towards the end of the surgery it looked like the devices needed more force and the surgeon kept turning the drivers until it snapped off. Four drivers were broken in the same way. There was minimal delay to remove screw driver fragments from patient. Doctor verified with x rays that the devices were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2018-00988 |
| MDR Report Key | 7531978 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2019-02-17 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-05-22 |
| 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 | MS SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| 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 | CONQUEST FN SCREWDRIVER |
| Generic Name | DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT |
| Product Code | JDO |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-05-10 |
| Catalog Number | 71179215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 71179215 | 1. Other; 2. Required No Informationntervention | 2018-05-22 |