MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-02-06 for AEZ LONG HANDLE MINI PIN & LIGATURE CUTTER 803-0503 manufactured by Ormco Corporation.
[15513564]
A doctor's office alleged that the blade from an aez mini ligature cutter had broken off of the device during a patient's procedure.
Patient Sequence No: 1, Text Type: D, B5
[15688822]
Patient details with regard to age, gender, and weight were not provided. It was confirmed that no serious injury was associated with this incident; the broken piece was collected immediately. The patient was not harmed and is doing fine. A visual test was performed on the returned device confirming that the cutting surface had broken away from the tip and a braze failure had occurred; however, the cause of the breakage was inconclusive. In addition, no similar complaints were received with regard to this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00002 |
| MDR Report Key | 2946742 |
| Report Source | 01,05,07 |
| Date Received | 2013-02-06 |
| Date of Report | 2012-11-01 |
| Date Mfgr Received | 2012-11-01 |
| Date Added to Maude | 2013-04-22 |
| 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 | MRS. WENDY GARMAN |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEZ LONG HANDLE MINI PIN & LIGATURE CUTTER |
| Generic Name | LIGATURE WIRE CUTTER |
| Product Code | EJB |
| Date Received | 2013-02-06 |
| Catalog Number | 803-0503 |
| Lot Number | 08H10H |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-06 |