MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 150MM, STERILE, PERC REF PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9733236

Device Problem Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

No devices were returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that, while malleting the perc pin and it broken while still inside the patient.There was a less than 1-hour delay to the procedure and no impact on patient outcome.The likely cause of the issue was the perc pin being hammered into a previously applied hardware.The surgeon decided to leave the broken piece inside the patient.

• Brand Name: 150MM, STERILE, PERC REF PIN
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11401565
• MDR Text Key: 234406969
• Report Number: 1723170-2021-00546
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994247865
• UDI-Public: 00613994247865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: 9733236
• Device Catalogue Number: 9733236
• Device Lot Number: 2020110320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 57