SROM TRI BAND CONE REAMER 23 Adverse Event — Malfunction (MDR 1818910-2020-11371)
SROM TRI BAND CONE REAMER 23 Adverse Event — Malfunction (MDR 1818910-2020-11371) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SROM TRI BAND CONE REAMER 23; Generic name: HIP INSTRUMENTS : REAMERS; Manufacturer: DEPUY ORTHOPAEDICS INC US.
| Device | SROM TRI BAND CONE REAMER 23 |
|---|---|
| Generic name | HIP INSTRUMENTS : REAMERS |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Report number | 1818910-2020-11371 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPU |
| Source | openFDA MAUDE (device adverse events) |
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