MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for EMAX 2 PLUS MOTOR EMAX2PLUS manufactured by Depuy Synthes Products Llc.
[184448122]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184448123]
It was reported from (b)(6) that the motor device was generating heat during operation. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The date of event was unknown but was known to have occurred in 2020. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00509 |
| MDR Report Key | 9855723 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2012-11-12 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| 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 | 2020-03-19 |