MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-11 for HU-FRIEDY #2 MOLT SINGLE END CURETTE CM2 manufactured by Hu-friedy Mfg. Co.,inc..
[15576067]
The curette was being used to extract a maxillary molar. The end of curette fractured while removing the remaining distal root tip. The tip fell into the maxillary sinus cavity through the oral antral opening that was created by the extraction.
Patient Sequence No: 1, Text Type: D, B5
[15871210]
Weight of pt is not known, office was not able to provide the info. Hu-friedy does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot # which is tied to the date of mfr. 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. Returned tip is broken approx 11. 4 mm from the tip. Broken tip was included. Returned instrument is old and worn. The broken tip is damaged. It is dull, chipped, and has gouges at the back of the working end. The remaining unbroken section (shank) is bent and does not match current product. Conclusion: breakage appears to have been the result of applying a force higher than material capability to the working end. These types of instruments (cm2) have a normal life expectancy of up to 4 years. The returned instrument was mfg almost 26 years ago (1985).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2011-00003 |
| MDR Report Key | 2306028 |
| Report Source | 06 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-10-07 |
| Date of Event | 2011-08-03 |
| Date Mfgr Received | 2011-09-16 |
| Device Manufacturer Date | 1985-01-01 |
| Date Added to Maude | 2012-07-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY #2 MOLT SINGLE END CURETTE |
| Generic Name | CM2 |
| Product Code | EKE |
| Date Received | 2011-10-11 |
| Returned To Mfg | 2011-09-16 |
| Model Number | CM2 |
| Catalog Number | CM2 |
| Lot Number | 1985 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO.,INC. |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-11 |