MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROMARK ENDO MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number	PMKEM1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that promark endo motor not running correctly, slow on all settings.No injury.
Additional Manufacturer Narrative
Evaluation received from aseptico - see attached report.Opening comments by (b)(6) : their unit is not performing as it should.They replaced the motor and it is still not working properly sending foot pedal closing comments: *console* replaced the power board, tested okay motor*, *foot pedal*, and the *pwr cord* tested okay complete date: 5/13/2024 initials: (b)(6).

• Brand Name: PROMARK ENDO MOTOR
• Common Device Name: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19231043
• Report Number: 2320721-2024-00028
• Device Sequence Number: 15198836
• Product Code: EKX
• UDI-Device Identifier: D716PMKEM11
• UDI-Public: D716PMKEM11
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Device Catalogue Number: PMKEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/01/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown