MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-05 for ULTRA DRIVE 7MM SPAGETTIBOHRER N/A 423871 manufactured by Biomet Orthopedics.
[18001973]
It was reported patient underwent a cement plug removal procedure on (b)(6) 2014. During the procedure, two disk drills fractured while removing a cement plug from the patient's femur. A fractured fragment remains in the patient. Cement was removed and a total hip system was implanted.
Patient Sequence No: 1, Text Type: D, B5
[18120261]
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 4 states, "do not attempt removal of a bone plug with the ultra-drive? Handpiece. The jolting force often required for removal of a bone plug can cause unrepairable, permanent damage to the handpiece. " this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-07557 / 07558).
Patient Sequence No: 1, Text Type: N, H10
[32707837]
Examination of returned device found no evidence of product non-conformance. Material analysis showed that both drills fractured nearly perpendicular to their shaft? S longitudinal axis. Discoloration was noted on the extension, which is consistent with either a loose connection or multiple uses of the tool. The returned parts showed signs of a bending fatigue, which the parts are not designed for. 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.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-07557 |
| MDR Report Key | 4064924 |
| Report Source | 01,05 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-09-22 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-09-22 |
| Device Manufacturer Date | 2014-01-14 |
| Date Added to Maude | 2014-09-05 |
| 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 SPAGETTIBOHRER |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2014-09-05 |
| Returned To Mfg | 2014-09-22 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 114600 |
| 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 | 2014-09-05 |