MAUDE Adverse Event Report: OSTEOMED, LLC SERIES III STRAIGHT DRILL; HANDPIECE, ROTARY BONE CUTTING

Model Number 450-0777

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed late because of an oversight during the investigation of this complaint in 2020 and subsequent recent review of complaints due to new management and postmarket personnel determined this complaint is mdr reportable.Two drills were returned for complaint (b)(4).This mdr is for one of the drills.The following is the investigation performed at the time of this complaint in 2020: two series iii straight drills were returned for evaluation and repair.The work order for repair indicated the issue was caused by worn and dirty bearings.Inventory review was performed which included 78pcs of lot numbers 1156259m (30pcs), 1154093m (30pcs) and 1151367 (18pcs).There were no non-conformities found during inventory review process.There were no capas and two ncr's initiated for part number 450-0777 during 2018 present timeframe.The two ncrs were unrelated to this issue.

Event Description

On (b)(6) 2020, the facility office manager reported they had two machines that were getting hot and burning the mucosa in the patient's mouths.It was reported there was no patient harm, and no treatment or medical intervention was necessary as a result of the burns.This report is for one of the devices associated with complaint (b)(4).

• Brand Name: SERIES III STRAIGHT DRILL
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: elhum wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 13242273
• MDR Text Key: 286644979
• Report Number: 2027754-2022-00004
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 450-0777
• Device Catalogue Number: 450-0241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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