MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for 4.0MM BURR AR-84000BE manufactured by Arthrex.
[53683197]
Patient underwent shoulder arthroscopy on (b)(6) 2016. During the procedure, metal shavings were released when the burr was used. The equipment was sent back to the manufacturer for evaluation. There was no adverse impact to the patient to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064437 |
| MDR Report Key | 5917209 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-07-06 |
| Date Added to Maude | 2016-08-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 4.0MM BURR |
| Generic Name | BURR |
| Product Code | HTT |
| Date Received | 2016-08-26 |
| Returned To Mfg | 2016-07-06 |
| Catalog Number | AR-84000BE |
| Lot Number | 10044031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX |
| Manufacturer Address | NAPLES FL 34106 US 34106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-26 |