MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PIN, 9733235, 100MM, STERILE, PERC REF; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9733235

Device Problem Material Integrity Problem (2978)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

No products have been returned to medtronic for analysis.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a spinal procedure.It was reported that while trying to remove the perc pin, a part of it broke off.The site did get the rest of the pin removed and then checked with x-rays to make sure no other part of the pin was remaining in the patient.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.

• Brand Name: PIN, 9733235, 100MM, STERILE, PERC REF
• 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: 11806492
• MDR Text Key: 250021470
• Report Number: 1723170-2021-01245
• Device Sequence Number: 1
• Product Code: OLO
• 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: 05/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 9733235
• Device Catalogue Number: 9733235
• Device Lot Number: 200825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 21 YR
• Patient Weight: 57