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.
[184437210]
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. Device evaluation: the actual device was returned for evaluation. During repair, it was determined that the reported condition was confirmed. The assignable root cause was determined to be due to component failure from normal wear. If additional information should become available, a supplemental medwatch report will be submitted accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184437211]
It was reported by (b)(6) that during service and evaluation, it was determined that the flex circuit and a component of the motor device was damaged. It was determined that the device generated heat and excessive noise. It was further determined that the device failed pretest for motor thermistor assessment: (between 1000 and 15k ohms), air pump assessment: (change in audible output), handpiece temperature assessment: (temperature shall not exceed 118? F), hand control assessment: (console speed range spans 0 to 80k? 1k rpm) and noise assessment: (sound level must not exceed 76 dba). It was noted in the service order that the hose was broken. 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 unknown. However, it was reported that the event occurred in 2020. All available information has been disclosed. If additional information should available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00529 |
| MDR Report Key | 9860035 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2017-07-20 |
| 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 |
| Returned To Mfg | 2020-03-05 |
| Model Number | EMAX2PLUS |
| 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 |