MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9735024

Device Problem Material Integrity Problem (2978)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The driver was returned for product analysis.As reported, the tip of the returned driver had been broken off.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that during cleaning, sterile processing tried to disassemble for cleaning and ended up breaking the tip trying to remove from the sleeve.The item was not able to be disassembled.The driver was broken.There was no patient present when this issue was identified.Additional information was provided stating that the hospital routinely disassembles tools during cleaning.

• Brand Name: DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN
• 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: 11634501
• MDR Text Key: 244434115
• Report Number: 1723170-2021-00930
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: 131219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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