MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA 4.75; SCREWDRIVER

Model Number	5484336
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
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 professional (hcp) via a medtronic representative regarding a patient implanted with a screw using a driver for a plif (intra-op).It was reported that the driver broke at final tightening.The instrument broke and there was no fragment of the instrument remaining in the patient's body.The event occurred at final tightening of screw on left l5.The tab on one side was broken off according to ifu, but the tip of the driver broke.The counter torque was used.After that, as a replacement, retaining screwdriver was used and final tightening was able to be performed, and the operation was able to be completed.The reported set screw was discarded, and no driver tip was left in the body.There were no patient symptoms or complications as a result of the event.The pre-op diagnosis was intervertebral disc herniation and levels implanted were l5/s.There was a delay of less than 60 minutes in the overall procedure time.No health damage in the patient was reported.The patient's medical history included asthma, spontaneous pneumothorax.No further complications were reported/ anticipated.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a screw using a driver for a plif.It was reported that the driver broke at final tightening.The instrument broke and there was no fragment of the instrument remaining in the patient's body.The event occurred at final tightening of screw on left l5.The tab on one side was broken off according to ifu, but the tip of the driver broke.The counter torque was used.After that, as a replacement, retaining screwdriver was used and final tightening was able to be performed, and the operation was able to be completed.The reported set screw was discarded, and no driver tip was left in the body.There were no patient symptoms or complications as a result of the event.The patient did not come in contact with the product.The pre-op diagnosis was intervertebral disc herniation and levels implanted were l5/s.There was a delay of less than 60 minutes in the overall procedure time.No health damage in the patient was reported.The product will not be replaced by a medtronic product.The patient's medical history included asthma, spontaneous pneumothorax.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part# 5484336, lot# fa16k009- visual inspection confirmed approximately 3mm of the instrument tip has been broken off, consistent with interface during usage.The remaining torx tip has been twisted.Fracture surface analysis revealed a fairly flat fracture surface and circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.H6: updated patient code, eval.Code method, eval.Code result post analysis.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 SOLERA 4.75
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10611916
• Report Number: 1030489-2020-01361
• Device Sequence Number: 13751225
• Product Code: HXX
• UDI-Device Identifier: 00613994946591
• UDI-Public: 00613994946591
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 5484336
• Device Catalogue Number: 5484336
• Device Lot Number: FA16K009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 70