MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-08 for HU-FRIENDLY SAS13/1498 manufactured by Hu-friedy Mfg. Co., Llc.
[3943949]
During a dental procedure on (b)(6) 2013, the tip of the device broke in the patient's mouth. There was no patient injury and no medical intervention required. The tip was retrieved and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[11247459]
The practice returned the broken device to hu-friedy on (b)(4) 2013. The returned device was reviewed and it was determined on (b)(4) 2013 that this was a non-reportable incident. However, on (b)(4) 2013, hu-friedy was notified by (b)(4)) that the practice reported the breakage. Therefore, hu- friedy is submitting this report on (b)(4) 2013. Returned instrument has been over-sharpened by the end user. The original shape of the working end has been altered and the cutting edge is excessively dull. Additionally, this type of instrument (scalers) has a normal life expectancy of 9-12 months. The returned instrument was manufactured june 2010. Section a- weight and age of patient is not known, office was not able to provide information. Section d- hu-friedy does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot number which is tied to the date of manufacture. The product involved in the event was a stainless steel instrument that does not have a expiration date. The device is not implanted, therefore, implant/explant dates are not applicable. Section g- #5: all are not applicable. This is a class 1 exempt device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2013-00005 |
| MDR Report Key | 3453066 |
| Report Source | 06 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-08 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | MARIA VRABIE, TEAM LEADER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIENDLY SAS13/1498 |
| Generic Name | 13/14 MINI 5 GRACEY EVEREDGE #9 HDL, BLUE |
| Product Code | EKE |
| Date Received | 2013-10-08 |
| Returned To Mfg | 2013-07-03 |
| Model Number | SAS13/1498 |
| Catalog Number | SAS13/1498 |
| Lot Number | 0610 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 NORTH ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-08 |