MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for TRACTION BOOT XLARGE 5855-865 manufactured by Mizuho Orthopedic Systems, Inc..
[183883481]
Inspection of the returned equipment found that a threaded stud had broken off the foot plate. The consequence of this is that the boot could separate from the traction unit. This could allow a patient's leg to fall, with a potential for a serious injury. More detailed inspection of the broken parts revealed a welding defect.
Patient Sequence No: 1, Text Type: N, H10
[183883482]
The user reported that during a procedure to repair a hip fracture, while the traction was being adjusted, a loud pop was heard. The equipment was checked, and nothing looked unusual, so the procedure continued. Later, when the patient's foot was rotated, it would not hold position. When the user attempted to tighten the handle more, a screw came off the boot. No patient injury was noted. While the prior reduction could not be achieved, the procedure was completed without the traction device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2020-00002 |
| MDR Report Key | 9574535 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACTION BOOT XLARGE |
| Generic Name | BOOT |
| Product Code | JEA |
| Date Received | 2020-01-10 |
| Model Number | 5855-865 |
| Catalog Number | 5855-865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 945871234 US 945871234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |