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

Model Number	7578900
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Delay in surgery of over 60 minutes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of compression fracture at l1, undergoing a posterior spinal fixation by pps of t11, t12, l2 and l3.It was reported that the button on the upper part of handle of the set screw driver was too hard to be pressed.One of the two products couldn't be used at all, and the other one was also hard, but it was managed to use it to the end.Pps was inserted from t11 to l3, and sas was used for th12.After the final tightening of ps at l2 and l3 was performed, distraction was performed with tra uma device, and kyphosis correction was performed.There was a delay of over 60 minutes.There were no patient symptoms/complications as a result of this event.The operation of button of the reported driver was not smooth, it could not be pressed at all, or even though the button could be pressed, it did not return.It had not been confirmed whether it was a spring problem or a shaft deformation.The reported product was consignment, but it had not been used for a while.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The products will be returned and will be replaced.
Additional Manufacturer Narrative
H3: product analysis: visual and optical examination analysis reveals that the locking tabs have been bent inwards of the tip of the driver which will not allow the center shaft of the instrument to function and the retaining pin has been bent and the hex edges of the compressor have been rounded.This is consistent with bend stress overload.B2: delay in procedure of over 60 minutes.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 SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10768525
• Report Number: 1030489-2020-01533
• Device Sequence Number: 13734807
• Product Code: LXH
• UDI-Device Identifier: 00613994644831
• UDI-Public: 00613994644831
• 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): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7578900
• Device Catalogue Number: 7578900
• Device Lot Number: SW18K030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR