MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HEIDBRINK ROOT TIP PICK; ELEVATOR, SURGICAL, DENTAL

Model Number EHB1

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight, ethnicity and race unknown.No relevant history.Based on the lot number of the device, this device was produced prior to the udi deadline for class 1 devices, therefore udi is not present.The device is not implanted, therefore implant/explant dates are not applicable.Reprocessor does not apply.No known concomitant medical products and therapy dates.User facility/importer does not apply.

Event Description

The dentist was performing an extraction when tooth #13 luxated and a root tip fractured.The dentist tried to grasp the tip but about 4mm of the tip of the root pick broke off.An x-ray was performed in the office and no metallic materials were found in sinus or nasal cavities.Patient was referred to radiology at hospital for further imaging as well as a urinalysis was performed.The hospital reports stated all x-rays were clear of the tip.

• Brand Name: HEIDBRINK ROOT TIP PICK
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• 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: 8445945
• MDR Text Key: 139671428
• Report Number: 1416605-2019-00006
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/22/2019

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
• Device Operator: No Information
• Device Model Number: EHB1
• Device Catalogue Number: EHB1
• Device Lot Number: 1989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1989
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR