MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-10 for ULTRA DRIVE 7MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[15819726]
It was reported patient underwent a total hip revision procedure on (b)(6) 2014 of competitor product. During the procedure, the tip of the ultra drive fractured. The fractured tip was removed from the patient. Regular instrumentation was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[16211379]
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 related to the event. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[27013877]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted the root cause of the instrument failure was likely due to conditions of use. As reported, the surgeon stated that the instrument was not used as intended. There are warnings in the package insert that state that this type of event can occur:? 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.?
Patient Sequence No: 1, Text Type: N, H10
[31191020]
This follow-up report is to correct information that was reported in error on a previous medwatch.
Patient Sequence No: 1, Text Type: N, H10
[31191021]
It was reported patient underwent a total hip revision procedure on (b)(6) 2014 of competitor product. During the procedure, the tip of the ultra drive fractured. The fractured tip was removed from the patient. Regular instrumentation was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2014-09055 |
| MDR Report Key | 4319225 |
| Report Source | 07 |
| Date Received | 2014-12-10 |
| Date of Report | 2015-02-02 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2015-02-02 |
| Device Manufacturer Date | 2014-01-29 |
| Date Added to Maude | 2014-12-11 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 | ULTRASONIC SURGICAL INSTRUMENT |
| Product Code | JXE |
| Date Received | 2014-12-10 |
| Returned To Mfg | 2014-12-09 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 333830 |
| ID Number | N/A |
| 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 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-10 |