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

Model Number	7485250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of origin is argentina.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 healthcare provider (hcp) via a manufacturer representative regarding a product used for spinal therapy.It was reported that during a procedure before using on patient, a broken screwdriver was identified.The procedure involved the patient in ventral recumbency with aseptic technique, midline incision, dissection by planes, hemostasis, subperiostic dissection from t3 to l3, placement of pedicular screws, and adjustment and correction of kyphosis.Radioscopy verification was performed, and there was no alteration of evoked potential.The procedure also included decortication of the sheet, placement of bone substitute and autologous material, drainage placement, and closure by plans.The instrument breakage did not result in any injury to the patient, did not extend hospitalization, and did not require medical or surgical intervention to prevent permanent impairment.No fragments of the instrument remained in the patient and no further complications reported.Additional information was received via manufacturer representative that the reported product was already used before.Additional information was received via manufacturer representative that the pre-op diagnosis of patient is kyphosis.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: product analysis of part# 7485250, lot# k23b1131 visual inspection confirmed the plastic cap of the driver has broken.Optical inspection did not reveal any damage to the driver that could contribute to the break.The damage is consistent with overload.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: CD HORIZON
• 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: 21444180
• Report Number: 1030489-2025-00958
• Device Sequence Number: 15393905
• Product Code: LXH
• UDI-Device Identifier: 00885074138473
• UDI-Public: (01)00885074138473(11)220810(10)K23B1131
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2025

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: 7485250
• Device Catalogue Number: 7485250
• Device Lot Number: K23B1131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/05/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 07/08/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: 13 YR
• Patient Sex: Female