MAUDE Adverse Event Report: OSTEOMED, LLC LEVER ARM MOTOR UNIT; HANDPIECE, ROTARY BONE CUTTING

Model Number	450-0034
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause cannot be determined with the available information.The device is a reusable instrument and was manufactured in 2018; therefore, it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.The device was tested upon manufacture and met all specifications.The sro work order diagnosis and possible root cause was determined to be "unit is continuously running due to a malfunctioning flex circuit in the cable assembly".Review of the complaint database revealed eleven (11) reported complaints in the last two (2) years for this issue (one of which is the complaint in this report).Based on the information received and the investigation performed, the root cause could not be determined.
Event or Problem Description
A service request for the device was received with no product complaint made.On (b)(6) 2024, the service request work order device diagnosis was completed.During the service request work order, it was noted "unit is is continuously running due to a malfunctioning flex circuit in the cable assembly ".As a result of these findings of the service request work order, this report is being submitted.Additionally, as a result of the service request work order, the customer was contacted to determine if any surgery or patient was impacted.The customer responded that this issue was noted in their warehouse prior to any surgery with no patient, user, or surgery involved.

• Brand Name: LEVER ARM MOTOR UNIT
• 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: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 19212678
• Report Number: 2027754-2024-00028
• Device Sequence Number: 20859455
• Product Code: KMW
• UDI-Device Identifier: 00845694015646
• UDI-Public: (01)00845694015646(30)1(11)180607
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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
• Operator of Device: Other
• Device Model Number: 450-0034
• Device Catalogue Number: 450-0034
• Device Lot Number: 1125393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown