ATTUNE IMPACTION HANDLE Adverse Event — Malfunction (MDR 1818910-2020-11391)
ATTUNE IMPACTION HANDLE Adverse Event — Malfunction (MDR 1818910-2020-11391) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ATTUNE IMPACTION HANDLE; Generic name: ATTUNE INSTRUMENTS : HANDLES; Manufacturer: DEPUY IRELAND - 9616671.
| Device | ATTUNE IMPACTION HANDLE |
|---|---|
| Generic name | ATTUNE INSTRUMENTS : HANDLES |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Report number | 1818910-2020-11391 |
| 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 REVEALED THE LOCKING MECHANISM WAS BROKEN. EXAMINATION OF THE RETURNED DEVICE REVEALED THE ATTUNE IMPACTION HANDLE HAD A BROKEN LEVER. ALL PIECES WERE RETURNED FOR EVALUATION. ROOT CAUSE AND CORRECTIVE ACTION ARE DOCUMENTED IN THE CAPA SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIO |
| Source | openFDA MAUDE (device adverse events) |
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