MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-28 for HU-FRIEDY 678-101L manufactured by Hu-friedy Mfg. Co., Llc.
[29717487]
The intended use of the 678-101l orthodontic distal end cutter is to cut orthodontic wire at the distal end of the oral cavity and hold the wire in the cutting blade while the jaws are engaged, until the instrument is removed from the oral cavity. The customer stated the cutter involved in this incident did not hold the wire due to a larger gap on a portion of the cutting blade, which caused the orthodontic wire to embed into the patient's cheek. There was an injury requiring the patient to see an oral surgeon. The customer stated that there seemed to be a large "curve" causing the lack of wire-holding ability. The instrument was returned to hu-friedy for evaluation. The evaluation revealed that the customer's observation was correct, and that the cutting surfaces did not mate correctly. Therefore, the wire did not hold in the jaws. The cutting surfaces not mating properly was caused by improper sharpening taking place during servicing of the instrument, which occured at hu-friedy in april of 2015. This malfunction was not part of the original manufacturing process, but a result of a servicing process on limited items. In addition, the instrument appears to be heavily used by the practitioner as indicated by the dull condition at tips, which may have contributed to the ability of the instrument to perform as intended. The device is not implanted, therefore implant/explant dates are not applicable.
Patient Sequence No: 1, Text Type: N, H10
[29717488]
Customer stated the cutters that he was using caused the wire to deflect into a patient's cheek. There was an injury requiring a patient to have to see an oral surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2015-00005 |
| MDR Report Key | 5183925 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-28 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-09-17 |
| Device Manufacturer Date | 2012-03-31 |
| Date Added to Maude | 2015-10-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Street | 3232 N. ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY |
| Generic Name | 678-101L |
| Product Code | JEX |
| Date Received | 2015-10-28 |
| Returned To Mfg | 2015-10-07 |
| Model Number | 678-101L |
| Catalog Number | 678-101L |
| Lot Number | 0312 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 N. ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-28 |