MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-08 for ARTHREX HEADED BIO-ABSORBABLE CORKSCREW AR-1921B manufactured by Arthrex.
[15445104]
Rptr is writing to inform fda of significant implant/medical device failure associated with the device: arthrex headed bio-absorbable corkscrew, ref # ar-1921b (order #), lot # (each bx has one assigned to it. ) many orthopaedic surgeons throughout the country have experienced a significant failure rate with this device. Rptr did notify the arthrex co. To date, they have pulled the product from the market, however, no formal recall and the co has not issued admission of product failure. These product failures have resulted in an approx 20% failure rate with return to surgery in approx 11/55 pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025495 |
| MDR Report Key | 403790 |
| Date Received | 2002-07-08 |
| Date Added to Maude | 2002-07-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX HEADED BIO-ABSORBABLE CORKSCREW |
| Generic Name | BIO-ABSORBABLE |
| Product Code | MBJ |
| Date Received | 2002-07-08 |
| Model Number | NA |
| Catalog Number | AR-1921B |
| Lot Number | VARIOUS |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 392781 |
| Manufacturer | ARTHREX |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-07-08 |