MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-10-29 for 5MM REVERSE CURETTE N/A 423859 manufactured by Biomet Orthopedics.
[15814041]
It was reported that the patient underwent a revision procedure of competitor? S components and the 5mm reverse curette fractured while extracting bone cement. The tip was retained in the patient's bone canal.
Patient Sequence No: 1, Text Type: D, B5
[16065589]
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: " intraoperative fracture or breakage of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-08440 |
| MDR Report Key | 4211818 |
| Report Source | 01,07 |
| Date Received | 2014-10-29 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2011-09-21 |
| Date Added to Maude | 2014-10-30 |
| 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 | 5MM REVERSE CURETTE |
| Generic Name | NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2014-10-29 |
| Model Number | N/A |
| Catalog Number | 423859 |
| Lot Number | 670910 |
| 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 | 2014-10-29 |