MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC DIVERGENCE MINI-PLATE SYSTEM; SCREWDRIVER

Model Number	6630904
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis #(b)(4): part # 6630904, lot # im21k054 visual and optical examination revealed the tip of the driver has broken.Optical inspection of the fracture surface revealed circular material displacement.This type of damage is consistent with torsional overload.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.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 a healthcare provider (hcp) via a medtronic representative regarding the drivers used in the c5-7 anterior cervical discectomy and fusion (acdf) surgery for degenerative disc disease at c5-7.It was reported that the tip of the t8 driver was broken off during an attempt to lock the zevo lock plate.The tip was not recovered but most likely was sucked up into the suction.No piece of the driver was found in the patient.The zevo drivers was stripped and no longer usable while implanting zevo screws.No adverse event occurred to patient.There were no further complications that were reported.

• Brand Name: DIVERGENCE MINI-PLATE 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: 21293491
• Report Number: 1030489-2025-00547
• Device Sequence Number: 21134205
• Product Code: HXX
• UDI-Device Identifier: 00643169363496
• UDI-Public: 00643169363496
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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: 6630904
• Device Catalogue Number: 6630904
• Device Lot Number: IM21K054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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: 75 YR
• Patient Sex: Male