MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for RASP CONMED ACL SPECIALS PART C8537.1 manufactured by Linvatec Corporation D/b/a Conmed Linvatec.
[141454376]
During knee surgery, rasp introduced to d? Bride cartilage. Rasp broke, piece floated to back of knee. Piece was retrieved via creation of posteromedial portal. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085673 |
| MDR Report Key | 8496692 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-02-06 |
| Date Added to Maude | 2019-04-09 |
| 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 | RISK MANAGER |
| 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 | RASP CONMED ACL SPECIALS |
| Generic Name | ROTATOR RASP |
| Product Code | HTR |
| Date Received | 2019-04-08 |
| Model Number | PART C8537.1 |
| Lot Number | 003 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINVATEC CORPORATION D/B/A CONMED LINVATEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |