MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-01 for ULTRA DRIVE 13MM DISC DRILL N/A 423871 manufactured by Biomet Orthopedics.
[18471867]
It was reported that patient underwent a cement removal procedure on (b)(6) 2013. During the procedure, the tip of the 7mm disk drill fractured and fell into the patient. The surgeon was able to retrieve the fractured pieces. The surgeon utilized a second tip and it fractured in the patient while removing cement from the femoral canal. As a result, the tip was removed from the patient and the surgeon completed the procedure successfully.
Patient Sequence No: 1, Text Type: D, B5
[18706150]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly and deviation. There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "the surgeon is to be thoroughly familiar with the equipment and the surgical procedure prior to performing surgery. " number 2 states, "do not force tool tips. Tools are to be guided, not forced. If the instrument meets resistance, do not force the tool, the tool may have contacted cortical bone. The application of force can cause damage to the cutting tip, the system and unnecessary damage to bone. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2013-02974 / 002975).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-02975 |
| MDR Report Key | 3258320 |
| Report Source | 01,07 |
| Date Received | 2013-08-01 |
| Date of Report | 2013-07-03 |
| Date of Event | 2013-07-02 |
| Date Mfgr Received | 2013-07-03 |
| Device Manufacturer Date | 2013-01-29 |
| Date Added to Maude | 2013-08-01 |
| 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 | MS. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA DRIVE 13MM DISC DRILL |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2013-08-01 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 016660 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-01 |