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.
[184302081]
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. The device was returned for evaluation. During repair, an evaluation was performed and it was determined that the reported condition was confirmed. The assignable root cause was traced to component failure due to normal wear. If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184302082]
It was reported from (b)(6) that during service and evaluation, it was determined that the motor device flex circuit was damaged, the device made excessive noise and was overheating. It was further determined that the device failed pretest for thermistor assessment, safety assessment, noise assessment, hand piece temperature assessment and hand control assessment. It was noted in the service order that the device head could not be locked. This event did not occur during surgery. There was no patient involvement. 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 will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2020-00527 |
| MDR Report Key | 9859956 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2010-12-10 |
| 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 | 2020-03-02 |
| 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 |