MAUDE Adverse Event Report: OSTEOMED, LLC POWER CONTROL CONSOLE 2I; HANDPIECE, ROTARY BONE CUTTING

Model Number 450-0005-00

Device Problem Unintended Power Up (1162)

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

Event Type  malfunction  

Manufacturer Narrative

The device had been returned under a service work order (sro) during which it was identified that the device was continuously running when the footswitch was plugged in and functioned incorrectly due to worn or damaged footswitch connector.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.A follow up report will be submitted upon completion of the investigation.A recall had been initiated for this device: reference number: 2027754-10/22/21-r.Recall number: z-0335-2022.Https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=190208.

Event Description

A service request for the device was received with no product complaint made.On (b)(6) 2022, the service request work order device diagnosis was completed.During the service request work order, it was noted the device ran continuously when the footswitch was plugged in and functioned incorrectly due to the worn or damaged footswitch connector.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.This report is related to report number 2027754-2022-00048 which is for the footswitch involved.

Manufacturer Narrative

Additional information was received on 06 october 2022 reporting there was no patient involvement when this issue was noted.Therefore, h6.Health effect- clinical code (annex e) and health effect- impact code (annex f) were updated to reflect this received information.

Manufacturer Narrative

The serial number of the device was reported as (b)(6) which is associated with lot number 1156582, so the dhr was reviewed for this lot number.Lot 1156582 released ten (10) units to inventory on 03/27/2021.Serial number (b)(6) was tested and met all specification requirements.All other inspections passed, and no issues were identified during dhr review.The device was returned per service work order (sro) (b)(4) and tested.All specifications were met.The diagnosis and possible root cause was identified to be "unit runs continuously due to a worn or damaged connector on the console used for connecting a foot control unit." the component was replaced as part of the warranty repair and retested to pass all specifications.The device is a reusable instrument and was manufactured in 2021; 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 sro assessment showed that the malfunction happened due to a damaged connector.The dhr review shows the device passes testing proving the connector was good as shipped.It is unknown what conditions in the customer environment caused for this damage.Due to the aforementioned information, the root cause of the damaged connector could not be determined.

• Brand Name: POWER CONTROL CONSOLE 2I
• 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: 15481934
• MDR Text Key: 303563556
• Report Number: 2027754-2022-00047
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K971692
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450-0005-00
• Device Catalogue Number: 450-0005-00
• Device Lot Number: 1156582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2027754-10/22/21-R
• Patient Sequence Number: 1