MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAS SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	25100401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding patient spinal therapy for t2-pe lvis revision.It was reported that the products were broken.There was patient involved in the event and no further complications or symptoms were reported.Additional information was received via manufacturer representative that all instruments that was reported are broken.All the instruments were used and broke during the same procedure.The lot number of ballast screwdriver is ct15l086 (b)(4) ballast screwdriver lot numbers: ct21a021 (b)(4), mas screw driver lot number: rs12f018 (09122013-021), ratcheting handle lot number: 37348.The procedure involved in the event was upsizing screws that were loose and replacing broken rods and levels implanted was t2-illiac but all the instruments were broken at the iliac screw.The reported products came in contact with the patient.
Additional Manufacturer Narrative
Product analysis: product# 25100401 lot# ct15l086 visual inspection confirmed the instrument tip has been broken off, consistent with interface during usage.Material hardness inspection confirmed conformance to print specification.Optical examination of the fracture surface revealed a fairly flat fracture surface and circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON BALLAS SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12553713
• Report Number: 1030489-2021-01227
• Device Sequence Number: 11787942
• Product Code: NKB
• UDI-Device Identifier: 00643169623996
• UDI-Public: 00643169623996
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• 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): 01/13/2022

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: 25100401
• Device Catalogue Number: 25100401
• Device Lot Number: CT15L086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male