COMPACT AIR DRIVE II Adverse Event — Malfunction (MDR 8030965-2020-03101)
COMPACT AIR DRIVE II Adverse Event — Malfunction (MDR 8030965-2020-03101) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COMPACT AIR DRIVE II; Generic name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A; Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | COMPACT AIR DRIVE II |
|---|---|
| Generic name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 8030965-2020-03101 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. HOWEVER, SINCE THE INVESTIGATION IS STILL ON-GOING, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. ONCE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI ¿ (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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