MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734724K DOUBLE PROCESS SHORT KIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734724K

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

This report pertains to seven of nine instruments with alleged inaccuracy.Mfg.Report# 1723170-2021-02970 pertains to instrument 1.Mfg.Report# 1723170-2021-02971 pertains to instrument 2.Mfg.Report# 1723170-2021-02972 pertains to instrument 3.Mfg.Report# 1723170-2021-02973 pertains to instrument 4.Mfg.Report# 1723170-2021-02974 pertains to instrument 5.Mfg.Report# 1723170-2021-02975 pertains to instrument 6.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2021 (b)(4), update (rep, hcp, for): during the procedure, there was an alleged inaccuracy of approximately 2mm due to instrument deformation during navigation.The procedure was completed by the use of backup products.The inaccuracy was isolated to the problem instruments.The reported issue did not result in a procedure delay.There was no impact on patient outcome.The likely cause was reported as instrument deterioration over time.

Manufacturer Narrative

H3: hardware analysis could not confirm the reported issue.The returned clamp was like new with no physical damage.The clamp was found to be fully functional.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: CLAMP 9734724K DOUBLE PROCESS SHORT KIT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13102232
• MDR Text Key: 290166571
• Report Number: 1723170-2021-02976
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734724K
• Device Catalogue Number: 9734724K
• Device Lot Number: 210121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1