MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-14 for BURR, ROUND, 8 FLUTE 4.0MM X 13CM AR-8400RBE manufactured by Arthrex, Inc..
[185224111]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[185224112]
It was reported that during a knee arthroscopy procedure, the round burr, ar-8400rbe, was being used for a notchplasty during an acl reconstruction. During use, metal debris was being discharged from the end of the burr into the knee. Or staff discarded the burr into the sharps container. Most of the debris was cleaned out with a shaver and a second round burr, ar-8400rbe, was opened to complete the case. During use, this round burr, with the same lot number as the first, also discharged metal debris. Again, the shavings were removed via shaver and the case was completed with a third round burr, ar-8400rbe, from a different lot number. Additional information provided 01/06/2020: patient's bone was hard. No pump was used during case; it was all gravity tubing. There was no interruption of fluid during use. The rep cannot confirm for sure that there was debris left behind. The staff and surgeon stated that they got the debris they could see out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01576 |
| MDR Report Key | 9585896 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-14 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-01-14 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURR, ROUND, 8 FLUTE 4.0MM X 13CM |
| Generic Name | BURR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GFF |
| Date Received | 2020-01-14 |
| Model Number | BURR, ROUND, 8 FLUTE 4.0MM X 13CM |
| Catalog Number | AR-8400RBE |
| Lot Number | 10387067 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |