MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PEDICLE ACCESS KIT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9733498
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the needles were damaged.It was noted that this issue was as product design failure.If any force is hammered onto the needle the needle breaks within the handle and needs to be replaced.There was no patient harm.The needle and trocar broke at the handle, so, they did break whilst within the patient anatomy.The problem was quickly solved by using pliers to remove both the needle and trocar.At no time was the needle or trocar broken within the bone.

• Brand Name: PEDICLE ACCESS KIT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10370042
• Report Number: 1723170-2020-02113
• Device Sequence Number: 972422
• Product Code: MAX
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131425
• 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
• Report Date (Section B): 08/05/2020

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 Expiration Date: 10/30/2021
• Device Model Number: 9733498
• Device Catalogue Number: 9733498
• Device Lot Number: 191031E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 80