MAUDE Adverse Event Report: OSTEOMED, LLC SERIES II LOW PROFILE MODULAR MOTOR UNIT

Model Number	450-0084
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, the customer contacted osteomed product manager, reporting that the osteomed 450-0021, power control console 2 with serial number (b)(4) was interfering with ge intercare and criticare monitors.The involved part numbers are as follows: complaint # part # description serial # (b)(4), 450-0021, power control console 2, (b)(4).(b)(4).450-0390, bmf footswitch, (b)(4).(b)(4), 450-0084, series ii low profile modular motor unit, (b)(4).
Additional Manufacturer Narrative
The investigation is on going and a supplemental report will be submitted on completion of investigation.
Additional Manufacturer Narrative
This report is related to report numbers 2027754-2021-00013 and 2027754-2021-00014 which are for the console and bmf footswitch involved in this event.The console 450-0021-00 sn (b)(6), footswitch 450-0390 sn (b)(6), and motor unit 450-0084 sn (b)(6) were returned for evaluation.The console 450-0021-00 sn: (b)(6) was manufactured under lot 1055201.A total of (b)(4) units were manufactured under this lot number.The device history record (dhr) was reviewed, and no issues were identified.The unit passed all inspections.The motor unit 450-0084, sn:(b)(6) was manufactured under lot# 1022389.The dhr was reviewed, and no issues were identified for sn: (b)(6).All inspections passed for this unit.The footswitch 450-0390 sn (b)(6) was manufactured under lot 1053682.A total of (b)(4) units were manufactured under this lot number.The dhr was reviewed, and no issues were identified.The unit passed all inspections.Evaluation of the returned devices were performed.Initial review did not show any external signs of damage.Visual verification (external) did not identify anything unusual other than the motor unit had a gap on the housing which was more than usual.Device was powered on and turned on and was functioning as expected.For further electromagnetic emissions analysis the device was taken to 3rd party test facility (nts testing, inspection and certification).A preliminary review for any electromagnetic emissions at normal turn on, forward and reverse running, using a detector/oscilloscope did not detect any interferences.Review of the user manual indicated there is guidance and manufacturer's declaration on electromagnetic emissions.The analysis performed as detailed above did not identify a failure in the system.Irrespective of this conclusion the console and footswitch have been recalled (recall number: (b)(4) as indicated in follow up 1 reports for 2027754-2021-00013 and 2027754-2021-00014).It was verified with the recall team that the customer advanced dental facilities have been notified of this recall and they have confirmed they do not have any other recall products in their location.The products returned per this complaint will be processed per the recall product disposition.

• Brand Name: SERIES II LOW PROFILE MODULAR MOTOR UNIT
• Common Device Name: SERIES II LOW PROFILE MODULAR MOTOR UNIT
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd.; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: flor rivera ; 3885 arapaho rd.; addison, TX 75001 ; 9726774600
• MDR Report Key: 12389476
• Report Number: 2027754-2021-00015
• Device Sequence Number: 4634323
• Product Code: GBB
• UDI-Device Identifier: 00845694012263
• UDI-Public: 00845694012263
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: 971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 450-0084
• Device Catalogue Number: 450-0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 06/30/2022
• 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