MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-07 for BLACKMAX-NEURO manufactured by Depuy Synthes Products Llc.
[183464523]
(b)(4). Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During service/repair, a visual and functional assessment was performed which determined that the device had low power? Failed initial rotational speed assessment. It was further determined that there was a hole in the hose near the muffler area and the vanes were worn. It was determined that the issues were consistent with improper maintenance. Therefore, the reported condition was confirmed. The assignable root cause was determined to be traced to maintenance, which is improper maintenance interval. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[183464524]
It was reported that during service and repair pre-testing, it was discovered that the motor device had low power. The event was not related to surgery. There was no patient involvement. There were no injuries or medical intervention associated with this event. The exact date of the event was unknown. However, it was reported that the event occurred in (b)(6) of 2020. 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 | 1045834-2020-00239 |
| MDR Report Key | 9684851 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2003-09-19 |
| Date Added to Maude | 2020-02-07 |
| 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 | BLACKMAX-NEURO |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT |
| Product Code | HBB |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2016-08-31 |
| Catalog Number | BLACKMAX-N |
| 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 | 2020-02-07 |