MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-08 for HU-FRIEDYNABERS PROBE WITH SATIN STEEL HANDLE PQ2N7 manufactured by Hu-friedy Mfg, Inc..
[19684563]
During a routine periodontal examination of pt's furcations, a hu-friedy nabers probe fractured below the gingival margin. The tip became lodged in the pt's gingival tissue and the periodontist entered the site surgically to remove the tip. The surgical site was closed with a non-absorbable suture. The pt returned to the periodontist's office on (b)(6) 2009 for removal of the suture, no complications occurred from the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[19709212]
A hu-friedy representative received an e-mail from dr. (b)(6) with info related to an adverse event caused by a hu-friedy nabers probe. The event occurred on (b)(6) 2009 and involved a (b)(6) male, no weight info was available. The instrument was returned on (b)(6) 2009 for eval by quality assurance. The instrument, which was manufactured in april of 2008, broke at the first 3mm marking. Visual and dimensional inspections revealed no manufacturing defects. Upon follow-up conversation with the doctor, it was determined that the instruments, which are thin and fragile at the working end, may be getting caught in the wire mesh basket of the ultrasonic bath used for cleaning of the instruments. This could lead to excessive stress on the instrument, which coupled with the force applied during the procedure exceeded the material's capability and caused the tip to fracture. Additional notes: the periodontist's office was not able to provide any weight info on the pt. Hu-friedy does not track our devices, which are mostly (b)(4) devices, by serial number, only a lot # which is tied to the date of manufacture. The product involved in the event was (b)(6) that does not have an expiration date. The device is not implanted, therefore, implant/explant dates are not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2009-00002 |
| MDR Report Key | 1378577 |
| Report Source | 07 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-05-03 |
| Date of Event | 2009-03-30 |
| Date Mfgr Received | 2009-04-03 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-09-29 |
| 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 VRABIE, MGR |
| Manufacturer Street | 3232 N. 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-FRIEDYNABERS PROBE WITH SATIN STEEL HANDLE |
| Generic Name | EIX - PERIODONTIC PROBE |
| Product Code | EIX |
| Date Received | 2009-05-08 |
| Returned To Mfg | 2009-04-03 |
| Model Number | PQ2N7 |
| Catalog Number | PQ2N7 |
| Lot Number | R8 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG, INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-08 |