MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for DRIVER manufactured by Biomet 3i.
[102082996]
Brand name unknown / not provided. Device product code unknown / not provided. Catalog number and lot number unknown / not provided. Pma/510(k) number unknown.
Patient Sequence No: 1, Text Type: N, H10
[102082997]
Doctor indicated implant fell to the floor while doctor was handling the implant with the driver. The driver had no good retention. Doctor used another driver to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2018-00192 |
| MDR Report Key | 7324050 |
| Date Received | 2018-03-08 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DANIA PEREZ |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DRIVER |
| Product Code | GFC |
| Date Received | 2018-03-08 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-08 |