MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-27 for 10.5 MM FLIP CUTTER II AR-1204AF-105 manufactured by Arthrex Inc..
[4488958]
The product is a 3. 5 mm drill that has a 10. 5mm reamer that remains in line with the drill until deployed. Once deployed, the drill becomes a reamer, 10. 5mm, at its tip. After this position deployed and engaged the cortex of the lateral femoral condyle, the reamer tip broke into several pieces. "i attached the product brochure for a better description. This is the same technique i've used in my approximately 75-100 acl reconstructions since starting here in (b)(6) 2012".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037026 |
| MDR Report Key | 3913202 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-06-03 |
| Date Added to Maude | 2014-07-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 10.5 MM FLIP CUTTER II |
| Generic Name | NONE |
| Product Code | HEX |
| Date Received | 2014-06-27 |
| Model Number | FLIP CUTTER II |
| Catalog Number | AR-1204AF-105 |
| Lot Number | 301539061 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX INC. |
| Manufacturer Address | NAPLES FL 34108 US 34108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |