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.
[1629465]
It was reported that patient underwent a procedure utilizing a knot pusher on (b)(6) 2010. The knot pusher cut the suture during the procedure. There was no delay to the procedure or injury to the patient as a result.
Patient Sequence No: 1, Text Type: D, B5
[8685022]
The information provided when this event was originally assessed indicated no delay to procedure or injury to the patient. Subsequently, a retrospective review performed (b)(6) 2010 determined that event meets reporting requirements as a device malfunction. 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. This report filed august 5, 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00308 |
| MDR Report Key | 1785224 |
| Report Source | 07 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-07-28 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-05-18 |
| Device Manufacturer Date | 2009-11-30 |
| Date Added to Maude | 2011-04-08 |
| 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 | 2010-05-18 |
| 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 | 2010-08-05 |