MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-09-16 for ULTRA-DRIVE TOOL 7MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[9353438]
Fracture surfaces of the disc drill have artifacts that suggest a fatigue fracture. There are warnings in the package insert that state that this type of event can occur: under warnings, number five 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". This report submitted (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
[9396233]
Medwatch report 1825034-2011-00823 is the only report related to this event. Medwatch report 1825034-2011-00824 is unrelated. This report submitted (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
[22134085]
The user facility is outside of the united states. No medwatch report was received. 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. There are warnings in the package insert that state that this type of event can occur: under warnings, number five 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". Only one of the three 7mm disk drills was returned for evaluation. The lots of the other two disk drills was not reported. All three disk drills fractured in the same location. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. This is mdr one of two (1825034-2011-00823 through 00824) for this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22232159]
It was reported that patient underwent elbow arthroplasty revision on (b)(6) 2011. When the surgeon attempted to use the 7mm disk drill, it fractured. Two more disk drills of the same size were also attempted for use, but they also fractured. The procedure was completed using an 11mm disk drill, with no reported injury to the patient or significant delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2011-00823 |
| MDR Report Key | 2252101 |
| Report Source | 01,07 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-08-19 |
| Date of Event | 2011-07-04 |
| Date Mfgr Received | 2011-08-19 |
| Device Manufacturer Date | 2011-02-25 |
| Date Added to Maude | 2012-06-26 |
| 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 | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| 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 | ULTRA-DRIVE TOOL 7MM DISK DRILL |
| Generic Name | DEVICE, NER |
| Product Code | JXE |
| Date Received | 2011-09-16 |
| Returned To Mfg | 2011-09-07 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 750860 |
| ID Number | N/A |
| Device Expiration Date | 2012-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-16 |