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

Model Number 450-0034

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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, and motor unit also has worn and dirty rotor 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 post surgery with no patient, user, or surgery involved.

Manufacturer Narrative

The device had been returned under a service work order (sro) during which it was identified that the device was continuously running due to malfunction of the cable assembly.The device is a reusable instrument and was manufactured in 2020; 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.Based on the information received and the investigation performed, the root cause could not be determined.

• Brand Name: LEVER ARM MOTOR UNIT
• Type of Device: 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: 17857713
• MDR Text Key: 324925256
• Report Number: 2027754-2023-00034
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 00845694015646
• UDI-Public: (01)00845694015646(30)1(11)200127
• Combination Product (y/n): N
• Reporter Country Code: ID
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450-0034
• Device Catalogue Number: 450-0034
• Device Lot Number: 1145682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1