MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-19 for ULTRA DRIVE 9.5MM DISK DRILL N/A 423872 manufactured by Biomet Orthopedics.
[3183983]
It was reported patient underwent a right hip arthroplasty on (b)(6) 2011. Subsequently, patient was revised on (b)(6) 2011 due to infection. The surgeon removed the stem and head and replaced with biomet stem and head and antibiotic bone cement. Further, patient was revised on (b)(6) 2013 due to infection and removed all items and replaced with biomet product. During the procedure, the disk drill bit fracture. To complete the procedure, the drill was still used, as well as a cement removal tool. As a result, the fractured piece remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
[10567701]
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 or deviation. There are warnings in the package insert that state that this type of event can occur: under warnings it states, "instruments, which have experienced extensive use or excessive force, are susceptible to fracture. " this report is number 2 of 8 mdrs filed for the same event (reference 1825034-2013-00293 / 00300).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-00294 |
| MDR Report Key | 2968261 |
| Report Source | 07 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-01-24 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-01-24 |
| Device Manufacturer Date | 2012-02-12 |
| Date Added to Maude | 2013-02-19 |
| 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 9.5MM DISK DRILL |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2013-02-19 |
| Model Number | N/A |
| Catalog Number | 423872 |
| Lot Number | 718210 |
| 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. Hospitalization; 2. Required No Informationntervention | 2013-02-19 |