SPECIALIST*2 UNIVERSAL HANDLE Adverse Event — Malfunction (MDR 1818910-2020-11402)
SPECIALIST*2 UNIVERSAL HANDLE Adverse Event — Malfunction (MDR 1818910-2020-11402) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPECIALIST*2 UNIVERSAL HANDLE; Generic name: KNEE INSTRUMENT : HANDLES; Manufacturer: DEPUY ORTHOPAEDICS INC US.
| Device | SPECIALIST*2 UNIVERSAL HANDLE |
|---|---|
| Generic name | KNEE INSTRUMENT : HANDLES |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Report number | 1818910-2020-11402 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED MALFUNCTIONING LOCKING MECHANISM, HOWEVER, THE INSTRUMENT WAS FOUND TO BE BROKEN. THE DAMAGE IS CONSISTENT WITH WEAR OUT THROUGH HEAVY USE AND SERVICING AND THE INVESTIGATION DID NOT ESTABLISH A NEED FOR CORRECTIVE ACTION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TI |
| Source | openFDA MAUDE (device adverse events) |
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