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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A service request for the device was received with no product complaint made.On (b)(6) 2023, the service request work order device diagnosis was completed.During the service request work order, it was noted the device was running continuously due to a malfunctioning 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 is being contacted to obtain additional information regarding these findings.
Additional Manufacturer Narrative
The device had been returned under a service work order (sro) during which it was identified.The device was continuously running due to malfunction of the cable assembly.The device is a reusable device.Attempts are being made to obtain further information regarding the findings of the sro, and a follow up report will be submitted if additional information is received and/or upon completion of the investigation.
Additional Manufacturer Narrative
Additional information was received on 14 april 2023 reporting the issue was noted when checked at the distributor's warehouse and was not noted during a procedure.Therefore, no patient was involved.Therefore, h6.Health effect-clinical code and health effect- impact code were updated.The invetigation was competed on (b)(6) 2023.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 per otr 0060 rev e upon manufacture and met all specifications.A review of complaint history determined there have been six (6) other reported complaints in the last two (2) years.Based on the information available and the investigation performed, the root cause could not be determined.

• 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: 16728879
• Report Number: 2027754-2023-00011
• Device Sequence Number: 6726782
• Product Code: KMW
• UDI-Device Identifier: 00845694015646
• UDI-Public: (01)00845694015646(30)1(11)181114
• 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,Followup
• Report Date (Section B): 04/18/2023

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: 450-0034
• Device Catalogue Number: 450-0034
• Device Lot Number: 1131876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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