MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for DHS?/DCS? COUPLING SCREW 338.31 manufactured by Wrights Lane Synthes Usa Products Llc.
[188845234]
Initial reporter is synthes sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188845235]
It was reported on (b)(6) 2020, the threaded tip of a dynamic hip and condylar screw system (dhs/dcs) coupling screw was found broken off. There was no patient involvement. This report is for one (1) dhs? /dcs? Coupling screw. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01210 |
| MDR Report Key | 9818067 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2003-06-23 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DHS?/DCS? COUPLING SCREW |
| Generic Name | EXTRACTOR |
| Product Code | HWB |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 338.31 |
| Catalog Number | 338.31 |
| Lot Number | 4603047 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |