MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-20 for EMAX 2 PLUS MOTOR EMAX2PLUS manufactured by Depuy Synthes Products Llc.
[184300667]
Device was used for treatment, not diagnosis. If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate. Concomitant medical products and therapy dates: footswitch device, console device, (b)(6) 2020. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184300668]
It was reported that during preventive maintenance, it was observed that water was seen in the drill connector of the motor device (the soak cap was on properly before cleaning). It was further reported that after leaving the connector to dry, the drill was plugged in to run the drill test. It was reported that the rotations per minute (rpms) fluctuated between 75,000 and 80,000 rpm as the motor struggled to maintain 80,000 rpm. It was further reported that the console device was not faulty because it was tested with two other drill devices and the drills maintain 80,000 rpm when the footswitch was fully depressed. The event was not related to surgery. There was no patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00525 |
| MDR Report Key | 9859905 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Street | 4500 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 | 3 |
| Brand Name | EMAX 2 PLUS MOTOR |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
| Product Code | HBC |
| Date Received | 2020-03-20 |
| Model Number | EMAX2PLUS |
| Catalog Number | EMAX2PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |