OSCILL-SAW Adverse Event — Malfunction (MDR 8030965-2020-03123)
OSCILL-SAW Adverse Event — Malfunction (MDR 8030965-2020-03123) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OSCILL-SAW; Generic name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A; Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | OSCILL-SAW |
|---|---|
| Generic name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 8030965-2020-03123 |
| 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 DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS TRACED TO IMPROPER MAINTENANCE. UDI: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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