MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND METAL CUTTER ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number ASMC

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that during posterior spinal fusion procedure the attachment tip part was broken.It was confirmed in the x-ray that there were no parts remained in the patient's body.It was also reported that there was no procedure delay due to this event and procedure was completed by continuously using the reported product.Additional information regarding the event was being followed up from the facility.

Manufacturer Narrative

No conclusion can be drawn.Device was returned and awaiting evaluation results.The user manual contains the following warnings ¿do not use a legend attachment if any part of the attachment appears to be bent, loose, missing or damaged.Do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff." in addition, ¿insert dissecting tool into motor collet with a slight rotational motion.A tactile and audible click is observed indicating that the dissecting tool is fully seated.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Report confirmed.Evaluation determined that the tip of the attachment was disassembled/detached.The likely cause of failure could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On follow up it was reported that there is no patient or staff impact and there was a delay of 30 minutes to 1 hour for checking all parts are available.

• Brand Name: LEGEND METAL CUTTER ATTACHMENT
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 14186547
• MDR Text Key: 289866045
• Report Number: 1625507-2022-00074
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASMC
• Device Catalogue Number: ASMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other