MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for DYONICS, FREER ELEVATOR * 4101 manufactured by Smith & Nephew Inc..
[57453]
During endoscopic carpal tunnel release, freer elevator inserted into incision. During use, tip broke off. Surgeon had to do open procedure rather than proceeding with endoscopic approach in order to retrieve piece which had broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 105099 |
| MDR Report Key | 105099 |
| Date Received | 1997-07-01 |
| Date of Report | 1997-05-05 |
| Date of Event | 1997-04-24 |
| Date Facility Aware | 1997-04-24 |
| Report Date | 1997-05-05 |
| Date Added to Maude | 1997-07-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYONICS, FREER ELEVATOR |
| Generic Name | ELEVATOR, ORTHOPEDIC |
| Product Code | GEG |
| Date Received | 1997-07-01 |
| Model Number | * |
| Catalog Number | 4101 |
| Lot Number | 283.04 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 103350 |
| Manufacturer | SMITH & NEPHEW INC. |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 381161804 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-01 |