MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-24 for BLACKMAX-NEURO manufactured by Depuy Synthes Products Llc.
[184427243]
(b)(4). This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. The assignable root cause was traced to improper maintenance. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[184427244]
It was reported that during service and repair/pre-testing, it was observed that the motor device had low power and the vanes were broken. The device also failed pretest for initial rotation speed assessment. The event was not related to surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown but was known to have occurred in 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 | 1045834-2020-00340 |
| MDR Report Key | 9745112 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2007-05-24 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2020-02-24 |
| Returned To Mfg | 2017-01-09 |
| 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 | 2020-02-24 |