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 Insufficient Information (4580)

Event Type  malfunction  

Event Description

A service request for the device was received on (b)(6) 2022 with no product complaint made.On (b)(6) 2022, the service request work order 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.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no anomalies were found.The review revealed the device had been tested and met specifications.Additionally, all inspections had passed.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 was repaired under the sro and was subsequently tested and met specifications.The device is a reusable instrument and was manufactured in 2016; therefore, it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.Based on the information available, the root cause could not be determined.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.

Manufacturer Narrative

Additional information received on 15 june 2022 after follow up attempts to obtain more information following the findings of the service repair.It was reported on 15 june 2022 that the issue with the device was the "lever arm motor unit was not working".No further information regarding how it was not working and the circumstances surrounding this issue was provided or available.

Manufacturer Narrative

H6: type of investigation- corrected to 10 (testing of actual/suspect device) and 3331 (analysis of production records).4117 (device not accessible for testing) was selected in error.

• 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: 14582947
• MDR Text Key: 300928036
• Report Number: 2027754-2022-00027
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 084569415646
• UDI-Public: (01)084569415646(30)1(11)20160317
• 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,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 1100448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Date Manufacturer Received: 06/15/2022
• 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