MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for UNKNOWN BURR DEVICE N/I manufactured by Depuy Synthes Power Tools.
[46575826]
Additional narrative: brand name, common device name, model and lot #, pma#, device manufacture date: the product code was unknown for the burr device. Therefore, the brand name, common device name, catalog number and 510k classification are unknown. The lot number was unknown; therefore, the device manufacture date is unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[46575827]
This is report 3 of 3 for the same event: it was reported that during an unspecified spine surgical procedure, it was discovered that the motor device and attachment device were smoking and running hot when used together with the burr device. There was a two to five minutes delay to the surgical procedure to obtain spare devices. The reporter stated that the surgery was completed successfully. There was patient involvement reported. 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 report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2016-11738 |
| MDR Report Key | 5661305 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-05-17 |
| 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 | RODNEY CRAIN |
| 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 POWER TOOLS |
| 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 | UNKNOWN BURR DEVICE |
| Generic Name | NI |
| Product Code | HTT |
| Date Received | 2016-05-17 |
| Catalog Number | N/I |
| Lot Number | N/I |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-17 |