MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MODULEX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5598007
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a frame and gear box.It was reported that marketing and pd ordered this set for a product demo and the frame and gear box did not mate.There was no patient involvement reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3.Device evaluation summary: product analysis #(b)(4): (b)(4) lot# em21d007 observations: both parts were returned with no physical events of damage or misuse.Functional testing revealed that the rack and the gearbox would not function together.I visual exam of the first tooth of the rack indicated that the form of the tooth and the size did not match the print.A dimensional check confirmed that the rack was not made to print.The first tooth of the rack should be smaller than the other teeth to allow the pinion of the gearbox to start.The first tooth on this rack is larger than the other teeth not allowing the pinon to start.Conclusion: 5598007 em21d007- manufactured incorrectly.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting gu idance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MODULEX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22401769
• Report Number: 1030489-2025-02385
• Device Sequence Number: 18244595
• Product Code: LXH
• UDI-Device Identifier: 00763000401535
• UDI-Public: (01)00763000401535(11)210616(10)EM21D007
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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: 5598007
• Device Catalogue Number: 5598007
• Device Lot Number: EM21D007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1574-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown