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 2020-03-20 for EMAX 2 PLUS MOTOR EMAX2PLUS manufactured by Depuy Synthes Products Llc.
[184433856]
Device was used for treatment, not diagnosis. The actual device was returned for evaluation. During repair, an evaluation was performed and it was determined that the device was generating heat. It was further determined that the device failed pre-test for noise assessment, safety assessment, handpiece temperature assessment. Therefore, the reported condition that the device was? Spoiled? Was confirmed. The assignable root cause of this condition was determined to be traced to component failure due to normal wear. 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
[184433857]
It was reported from (b)(6) that during service and evaluation, it was determined that the flex circuit of the motor device was damaged, the device was generating heat, and was making excessive noise. . It was further determined that the device failed pretest for hand control assessment, noise assessment, safety assessment, handpiece temperature assessment, no short circuit between sensor gnd and connector body, no short circuit between 5vdc line and connector body, no short circuit between hall sensor and connector body, and no short circuit between phases and connector body, and motor thermistor assessment. It was noted in the service order that the device? Spoiled?. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. . The exact date of the event was not reported, however, it was reported that the event 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 | 1045834-2020-00524 |
| MDR Report Key | 9860028 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2009-10-08 |
| 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 | MS. 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, DRILL, ELECTRIC - HANDPIECE |
| Product Code | HBC |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | EMAX2PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 |