MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-03-21 for ULTRA DRIVE 7MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[4243556]
It was reported patient underwent a total hip revision procedure on (b)(6) 2014. During the procedure, the tip of the disk drill fractured in the patient's distal femur canal. The fractured tip remains in the patient. An ultra drive tip was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11594101]
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, number 5 states, "the patient is to be warned that ultra-drive tool tips can break or otherwise fail during surgery, and that fragments of broken tool tips can remain at the surgical site after surgery. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-02028 |
| MDR Report Key | 3691922 |
| Report Source | 01,07 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-02-21 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-02-21 |
| Device Manufacturer Date | 2013-03-12 |
| Date Added to Maude | 2014-03-21 |
| 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. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. 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 7MM DISK DRILL |
| Generic Name | DEVICE |
| Product Code | JXE |
| Date Received | 2014-03-21 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 670180 |
| 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 | 2014-03-21 |