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

Model Number 450-0034

Device Problem Power Problem (3010)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A service request for the device was received with no product complaint made.On 09 march 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 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 is being contacted to obtain additional information regarding these findings.

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 flex circuit in the cable assembly.The device was repaired under the sro and was subsequently tested and met specifications.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 after completion of the investigation.

Manufacturer Narrative

Additional information was received on 13 march 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 07 april 2023.The device is a reusable instrument and was manufactured in 2022; 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 four (4) 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
• 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: 16570103
• MDR Text Key: 311698270
• Report Number: 2027754-2023-00008
• Device Sequence Number: 1
• Product Code: KMW
• 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,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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