AIR REAMER/DRILL II Adverse Event — Malfunction (MDR 8030965-2020-03098)
AIR REAMER/DRILL II Adverse Event — Malfunction (MDR 8030965-2020-03098) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AIR REAMER/DRILL II; Generic name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A; Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | AIR REAMER/DRILL II |
|---|---|
| Generic name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 8030965-2020-03098 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | 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. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE |
| Source | openFDA MAUDE (device adverse events) |
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