MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-19 for HU-FRIEDY #23/UNC 15 EXPRO, #7 HANDLE XP23/UNC7 manufactured by Hu-friedy Mfg. Co., Llc.
[21311414]
During a dental examination to measure pocket depths on (b)(6) 2013, the tip of the device broke in the patient's mouth. Measurement was taken on the upper left jaw in region 27. The tip was removed and patient is fine. The practice returned the broken device to our hu-friedy on (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
[21486723]
Returned instrument appears to have broken by applying repetitive force (back and forth) higher than material capability, causing tip to bend and eventually resulting in breakage. We currently have a very low level of returns for this product over the last 12 months. Therefore, no further action will take place at this time but we will continue to monitor. Weight and age of patient is not known, office was not able to provide information. 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 an expiration date. The device is not implanted, therefore, implant/explant dates are not applicable. Pma/510(k): all are not applicable. This is a class 1 exempt device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2013-00002 |
| MDR Report Key | 3247580 |
| Report Source | 06 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-05-07 |
| Date Mfgr Received | 2013-06-21 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2013-08-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA VRABLE |
| 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-FRIEDY #23/UNC 15 EXPRO, #7 HANDLE |
| Generic Name | #23/UNC 15 EXPRO, #7 HANDLE |
| Product Code | EJB |
| Date Received | 2013-07-19 |
| Returned To Mfg | 2013-06-21 |
| Model Number | XP23/UNC7 |
| Catalog Number | XP23/UNC7 |
| Lot Number | 0810 |
| 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 | 1. Other | 2013-07-19 |