MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC; PLIER, ORTHODONTIC

Model Number	866-2013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Laceration(s) (1946); Tooth Fracture (2428)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine activation appointment while crimping the stops on a maxillary 19x25tma arch wire the beak of an ormco weinghart plier broke intra-orally.This resulted in a slip & fracture of the mesial incisal corner of the patient's #21 as well as a small laceration of the attached gingival apical to the #21 & a small cut in the maxillary lip near the vermillion border.

• Common Device Name: PLIER, ORTHODONTIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8889206
• Report Number: 1416605-2019-00016
• Device Sequence Number: 14067710
• Product Code: JEX
• UDI-Device Identifier: 00889989082173
• UDI-Public: (01)00889989082173
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 866-2013
• Device Catalogue Number: 866-2013
• Device Lot Number: C18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR