MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ATT MR8 FOOTED; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-AF01
Medical Device Problem Codes	Material Twisted/Bent (2981); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation determined that the attachment leg is bent.The likely cause of failure could not be determined.It was also noted that foot has a sharp edge.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.
Event or Problem Description
Repair request initiated for device with no reported malfunction.No patient impact reported.Repair escalated to product event on evaluation due to leg of the attachment was bent.Additional information regarding the patient impact was being followed up from the facility.Date of event notification: on (b)(6) 2022.

• Brand Name: ATT MR8 FOOTED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• 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: 15842670
• Report Number: 1625507-2022-00271
• Device Sequence Number: 6909762
• Product Code: HBE
• UDI-Device Identifier: 00643169912397
• UDI-Public: 00643169912397
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR8-AF01
• Device Catalogue Number: MR8-AF01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown