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

Model Number	450-0777
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2027754-2022-00004
• Device Sequence Number: 4569283
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 450-0777
• Device Catalogue Number: 450-0241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown