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 |