MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ENDOSKELETON TCS INTERBODY SYSTEM; SCREWDRIVER

Model Number	5210-1067-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, friend/family member) regarding a patient having pre-operative diagnosis for stenosis.Procedure or technique used was acdf.Levels implanted c3-4.It was reported that while using this driver the tip cracked.It could no longer be used.The small driver bit was broken at the end of the case.The procedure was completed without delay or negative consequences to the patient.There was no fragment left inside the patient.There was no patient symptom reported.There were no further complications reported regarding the event.The product did not come into contact with the patient.When loading a screw, it was discovered it was broken.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.This regulatory report is being submitted due to retrospective review through capa 624392.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Corrected b5 and g2.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.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare professional, friend/family member) regarding a patient having pre-operative diagnosis for stenosis.Procedure or technique used was acdf.Levels implanted c3-4.It was reported that while using this driver the tip cracked.It could no longer be used.The small driver bit was broken at the end of the case.The procedure was completed without delay or negative consequences to the patient.There was no fragment left inside the patient.There was no patient symptom reported.There were no further complications reported regarding the event.The product did not come into contact with the patient.When loading a screw, it was discovered it was broken.

• Brand Name: ENDOSKELETON TCS INTERBODY SYSTEM
• Common Device Name: SCREWDRIVER
• 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: 21273122
• Report Number: 1030489-2025-00469
• Device Sequence Number: 11714803
• Product Code: HXX
• UDI-Device Identifier: 00191375052746
• UDI-Public: 00191375052746
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 5210-1067-90
• Device Catalogue Number: 5210-1067-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/05/2025
• 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 Age: 67 YR
• Patient Sex: Unknown