MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANCELLOUS BIT 3MM UC DRIL; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 960-527

Device Problems Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

No parts have been returned to the manufacturer 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 for an orthopedic trauma procedure.It was reported that the tip of the 2.1 drill broke off in the patient while drilling in the sacroiliac region for a combination luminous/open right hip replacement.The surgeon was unable to retrieve the drill bit tip, was aware it will remain retained, and proceeded with the procedure.The site only used navigation on these procedure for the universal drill guide to help gain the proper trajectory.It was noted that the site usually used a 960-524 3mm bit, but it had been dropped off the sterile field.The surgeon proceeded with the 960-527 3mm cancellous bit with a 2.1mm tip (approximately 27mm).The length of that 2.1 mm tip was what was retained in the patient.The surgeon stated that there was no impact on patient or procedure.There was no surgical delay and the instrument was discarded.

• Brand Name: CANCELLOUS BIT 3MM UC DRIL
• Type of Device: NEUROLOGICAL 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: 11874167
• MDR Text Key: 252312950
• Report Number: 1723170-2021-01375
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974161
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-527
• Device Catalogue Number: 960-527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 77 YR
• Patient Weight: 53