MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-11 for BIOKNOTLESS RC ANCHOR WITH ETHIBOND 212738 * manufactured by Mitek Worldwide.
[374815]
Patient to or for arthroscopic right rotator cuff repair. While attempting to use anchor, anchor end leg broke. Second anchor was seated on top of broken flange that was impacted in bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 566181 |
| MDR Report Key | 566181 |
| Date Received | 2005-01-11 |
| Date of Report | 2005-01-11 |
| Date of Event | 2004-12-10 |
| Report Date | 2005-01-11 |
| Date Reported to FDA | 2005-01-11 |
| Date Added to Maude | 2005-01-20 |
| 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 | BIOKNOTLESS RC ANCHOR WITH ETHIBOND |
| Generic Name | FIXATION DEVICE, ORTHOPEDIC |
| Product Code | NOV |
| Date Received | 2005-01-11 |
| Model Number | 212738 |
| Catalog Number | * |
| Lot Number | 1202605 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555967 |
| Manufacturer | MITEK WORLDWIDE |
| Manufacturer Address | 249 VANDERBILT AVENUE NORWOOD MA 02062 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-11 |