MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-05 for CLOSED KNOT PUSHER N/A 902813 manufactured by Biomet Sports Medicine.
[19619349]
The event is being reported as a serious injury due to the delay of greater than thirty minutes to the procedure. Evaluation of the component confirmed the absence of a radius in the thru-hole diameter. Biomet specifications include the creation of a radius on the thru-hole diameter to eliminate edge. A decision was made to recall the product. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
[19842640]
It was reported that patient underwent a procedure utilizing a closed knot pusher on (b) (6) 2010. During the procedure, the knot pusher cut the suture when the surgeon was tying knot on the anchor that was implanted. An additional knot pusher was retrieved and another anchor and suture were placed, however, a delay of greater than thirty minutes occurred as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2010-00310 |
| MDR Report Key | 1785227 |
| Report Source | 07 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-07-14 |
| Date of Event | 2010-07-13 |
| Date Facility Aware | 2010-07-28 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2009-11-30 |
| Date Added to Maude | 2010-08-05 |
| 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 | 3 |
| Manufacturer Contact | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET SPORTS MEDICINE |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1825034-2010-007R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLOSED KNOT PUSHER |
| Generic Name | PUSHER |
| Product Code | HXO |
| Date Received | 2010-08-05 |
| Returned To Mfg | 2010-07-19 |
| Model Number | N/A |
| Catalog Number | 902813 |
| Lot Number | 948870 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-08-05 |