MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-20 for FEMORAL STARTER RASP N/A 31-555402 manufactured by Biomet Orthopedics.
[1677270]
It was reported that patient underwent a hip procedure on (b)(6) 2010. During the procedure, the tip of the femoral rasp fractured and was retained by the patient. The fractured portion was not removed. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[8898608]
Current information is insufficient to permit a conclusion as to the cause of the event. The lot number information needed to review device history records was unavailable. The following sections could not be completed without proper product identification: discoloration, scratches and marks typically seen in surgical instruments. The rasp cutting edges are worn and the tip has fractured perpendicular to the axis of the rasp. There are shiny spots on the fracture surface indicating post-fracture damage. Fracture surface artifacts suggest the fracture occurred with multiple origins and began with fatigue. The user facility was notified of the event on (b)(6) 2010. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. This report filed (b)(6) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00609 |
| MDR Report Key | 1903924 |
| Report Source | 07 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-10-22 |
| Date of Event | 2010-10-21 |
| Date Facility Aware | 2010-11-04 |
| Date Mfgr Received | 2010-10-22 |
| Date Added to Maude | 2010-11-22 |
| 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 ORTHOPEDICS |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL STARTER RASP |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2010-11-20 |
| Returned To Mfg | 2010-10-26 |
| Model Number | N/A |
| Catalog Number | 31-555402 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-11-20 |