MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for FOREARM REDUCTION UNIT 3346 manufactured by Mizuho Orthopedic Systems, Inc..
[130491117]
The cause of the break was due to a cold shut casting defect with a void in the material.
Patient Sequence No: 1, Text Type: N, H10
[130491118]
It was reported the end user received a new forearm reduction unit (aka finger trap). The end user was using it on a patient and it broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2018-00037 |
| MDR Report Key | 8162052 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2018-12-13 |
| 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 | 0 |
| Brand Name | FOREARM REDUCTION UNIT |
| Generic Name | FINGER TRAP |
| Product Code | HST |
| Date Received | 2018-12-13 |
| Returned To Mfg | 2017-10-25 |
| Model Number | 3346 |
| Catalog Number | 3346 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-13 |