MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	75446535
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from initial reporter via medtronic field representative regarding an event happened during an intra-op for a p re-operative diagnosis of lumbar degenerative disease.It was reported that during the screw implantation process, the tip of the screwdriver was broken in the screw.After the screw was removed, a new screw was implanted and the operation continued.The status of the screw remained as explanted-complete.There were no patient symptoms were reported due to this event.There were no complications to patient/physician were reported/anticipated.Additional information received on 31-jul-2020: the damaged screw was replaced with new screw in the same surgery.
Additional Manufacturer Narrative
H3: product analysis #(b)(4):(b)(4) lot# h5483385 analysis found, after visual and optical examination and functional testing, it does not appear to be any damage nor does it indicate any functional issues with the screw.There are some witness marks in the hex area.The screw and the broken hex driver tip where received separated.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
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• MDR Report Key: 10424063
• Report Number: 1030489-2020-01096
• Device Sequence Number: 2938663
• Product Code: KWP
• UDI-Device Identifier: 00885074134109
• UDI-Public: 00885074134109
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 75446535
• Device Catalogue Number: 75446535
• Device Lot Number: H5483385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR