MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for BLACKMAX-NEURO manufactured by Depuy Synthes Products Llc.
[117161989]
The actual device was returned for evaluation. Reliability engineering evaluated the device and identified no failure. Therefore, the reported condition was not confirmed and assignable root cause was not determined. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[117162110]
It was reported that prior to surgery, it was observed that the motor device was leaking oil. 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 | 1045834-2018-51468 |
| MDR Report Key | 7777889 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2011-10-05 |
| Date Added to Maude | 2018-08-13 |
| 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 | KATE KARBERG |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| 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 | 0 |
| Brand Name | BLACKMAX-NEURO |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - HANDPIECE |
| Product Code | HSZ |
| Date Received | 2018-08-13 |
| Returned To Mfg | 2018-08-01 |
| Catalog Number | BLACKMAX-N |
| Lot Number | NA |
| 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 | 2018-08-13 |