MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; 678-101L

Model Number 678-101L

Device Problem Defective Component (2292)

Patient Problem Perforation (2001)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

The intended use of the 678-101l orthodontic distal end cutter is to cut orthodontic wire at the distal end of the oral cavity and hold the wire in the cutting blade while the jaws are engaged, until the instrument is removed from the oral cavity.The customer stated the cutter involved in this incident did not hold the wire due to a larger gap on a portion of the cutting blade, which caused the orthodontic wire to embed into the patient's cheek.There was an injury requiring the patient to see an oral surgeon.The customer stated that there seemed to be a large "curve" causing the lack of wire-holding ability.The instrument was returned to hu-friedy for evaluation.The evaluation revealed that the customer's observation was correct, and that the cutting surfaces did not mate correctly.Therefore, the wire did not hold in the jaws.The cutting surfaces not mating properly was caused by improper sharpening taking place during servicing of the instrument, which occured at hu-friedy in april of 2015.This malfunction was not part of the original manufacturing process, but a result of a servicing process on limited items.In addition, the instrument appears to be heavily used by the practitioner as indicated by the dull condition at tips, which may have contributed to the ability of the instrument to perform as intended.Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number, only by 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.

Event Description

Customer stated the cutters that he was using caused the wire to deflect into a patient's cheek.There was an injury requiring a patient to have to see an oral surgeon.

• Brand Name: HU-FRIEDY
• Type of Device: 678-101L
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 5183918
• MDR Text Key: 30230806
• Report Number: 1416605-2015-00003
• Device Sequence Number: 1
• Product Code: EIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 678-101L
• Device Catalogue Number: 678-101L
• Device Lot Number: 0312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR