MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-21 for HU-FRIEDY KIRKLAND KNIFE KK15/16 manufactured by Hu-friedy Mfg. Co.,inc..
[1735194]
On (b)(6) 2010, hu-friedy's quality assurance manager was informed by dr. (b)(6) that a male patient in his (b)(6) was having a gingivoplasty performed when the end of a hu-friedy kirkland knife fractured. The patient had a reflexive reaction and swallowed the tip of the blade. Dr. (b)(6) sent the patient to a gastroenterologist, who removed the fractured end of the knife from the patient via an endoscopy. Dr. (b)(6) reports that the patient is doing fine and had no further complications. The incident took place on (b)(6) 2010. Dr. (b)(6) did not inform hu-friedy at the time of the incident because the patient had no complications. During a routine visit from a hu-friedy sales representative, the doctor mentioned the incident and the hu-friedy sales representative sent the information over to the quality department for follow-up.
Patient Sequence No: 1, Text Type: D, B5
[8920728]
Weight of patient is not known, office was not able to provide the information. 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 manufacture. The product involved in the event was a (b)(4) instrument that does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable. Dr. (b)(6) returned a group of instruments to hu-friedy for replacement and the broken kk15/16 kirkland knife was included in that return without any indication that it was a device which had broke in a patient mouth and was involved in an adverse event. Our technical services department replaced his instruments and disposed of the returned instruments per standard procedure. At the same time, a separate return notification was opened in our system and was awaiting the return of this instrument which clearly described that we were awaiting an instrument involved in an adverse event. That notification remained open and upon further investigation, it was determined that the instrument was already returned with another group of instruments. By the time this was discovered, the instrument could not be recovered for evaluation. Quality returns for this device are very low, approximately (b)(4) per year and no previous adverse events with this product have been reported. No further investigation was conducted by hu-friedy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2010-00003 |
| MDR Report Key | 1884993 |
| Report Source | 05,06 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-01-25 |
| Date Mfgr Received | 2010-09-21 |
| Device Manufacturer Date | 1993-01-01 |
| Date Added to Maude | 2012-03-13 |
| 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, TEAM LEADER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| 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 KIRKLAND KNIFE |
| Generic Name | KK15/16 |
| Product Code | EIX |
| Date Received | 2010-10-21 |
| Model Number | KK15/16 |
| Catalog Number | KK15/16 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO.,INC. |
| Manufacturer Address | 3232 NORTH ROCKWELL ST. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-21 |