MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-22 for CLOSED KNOT PUSHER N/A 902813 manufactured by Biomet Sports Medicine, Inc..
[18181514]
It was reported that patient underwent bankart labral repair procedure on (b)(6) 2011. During the procedure, as the doctor attempted to push a western knot down the labrum, the suture was cut. A competitor's product was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[18205333]
Evaluation of returned device found the radius on the business end of the knot pusher had a sharp edge. This report submitted march 22, 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00197 |
| MDR Report Key | 2026871 |
| Report Source | 07 |
| Date Received | 2011-03-22 |
| Date of Report | 2011-02-21 |
| Date of Event | 2011-02-17 |
| Date Mfgr Received | 2011-02-21 |
| Device Manufacturer Date | 2010-05-03 |
| Date Added to Maude | 2011-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. VICTOR RODGERS |
| Manufacturer Street | 56 E. BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743713800 |
| Manufacturer G1 | BIOMET SPORTS MEDICINE, INC. |
| Manufacturer Street | 56 E. BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLOSED KNOT PUSHER |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2011-03-22 |
| Model Number | N/A |
| Catalog Number | 902813 |
| Lot Number | 250210 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE, INC. |
| Manufacturer Address | 56 E. BELL DRIVE P.O. BOX 587 WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-22 |