MAUDE Adverse Event Report: OSTEOMED, LLC EXTREMILOCK FOOT SYSTEM TRAY; PLATE, FIXATION, BONE

Model Number 320-2900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.

Event Description

It was reported for a procedure scheduled on (b)(6) 2022, the facility noticed a hole in the blue wrap/sterilization paper around the extremilock foot plating system tray and therefore had to cancel the procedure.This was prior to patient contact, and the patient was not in the room yet.There was no issue with the extremilock foot plating sytem tray itself.This issue was with how the facility sterilized the tray/ was an issue with the blue wrap.The field representative reported this was the second occurrence of this issue.The second occurrence is documented in report number 2027754-2022-00053.

Manufacturer Narrative

Sections d4.Udi, d4.Serial number, and h4.Device manufacture date completed as review of manufacturing and inspection records has been completed.The device was not returned for evaluation.No issues were reported with the device itself.The device history record (dhr) was reviewed for lot 1095854.All inspections passed and no issues were identified in the dhr review.A two year review (november 2020 - october 2022) of the complaint database found two(2) complaints for the extremilock trays and modules.One of the complaints is the complaint addressed in this report.The other complaint is addressed in report number 2027754-2022-00053.The same tray, serial number (b)(6), was used in both cases.Review of the instructions for use (ifu) revealed the "sterility" section of the ifu outlines the recommendations for autoclaving the extremilock trays.The ifu states "osteomed recommends using aesculap rigid containers and paper filters.The extremilock foot plating system (e-fps) contents need to be split and loaded into 2 aesculap extra-long rigid containers.The large tray insert from the upper level needs to be loaded into an aesculap extra-long basket, p/n jf232r, and then the basket is lowered into an extra-long rigid container, p/n jn445/jk490 (bottom/lid).The remaining components from the e-fps shipping container, the 4 upper modules and the 5 lower modules, are to be loaded into another extra-long basket, p/n jf232r, and then loaded into the second aesculap extra-long rigid container, p/n jn445/jk490 (bottom/lid).Modules 320-2906 and 320-2904 need to be stacked on top of each other".This information was relayed to the field who reported they would communicate this with the facility as the facility does have aesculap containers.Based on the information received and the investigation performed, the root cause of the hole in the blue wrap could not be determined.

Manufacturer Narrative

Corrected data: b3.Date of event was incorrectly reported as 10/12/2022.B3.Was updated to reflect the correct event date of 10/14/2022.Additional information/clarification was received on 20 october 2022 reporting for the procedure on (b)(6) 2022, the issue occurred during the procedure and not prior to patient contact as previously reported.Tthe patient was put under anesthesia.After the surgical tech found a hole in the wrapping of the tray, the case was then canceled after the patient woke up from general anesthesia.

• Brand Name: EXTREMILOCK FOOT SYSTEM TRAY
• Type of Device: PLATE, FIXATION, BONE
• 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: 15638968
• MDR Text Key: 302076293
• Report Number: 2027754-2022-00052
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 0845694043175
• UDI-Public: (01)0845694043175(30)1(11)20151118
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-2900
• Device Catalogue Number: 320-2900
• Device Lot Number: 1095854
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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
• Patient Outcome(s): Other