MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734298

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).The suspect tap has been received by the manufacturer for evaluation.The reported issue was confirmed as the tip of the instrument has been bent and broken off.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A site representative reported that during spinal fusion procedure, the tip of the tap was bent.It was reported that the issue occurred when the surgeon was malleting pelvic bone on the patient.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient outcome.

• Brand Name: 4.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7285712
• MDR Text Key: 100669288
• Report Number: 1723170-2018-00786
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2018

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: Physician
• Device Catalogue Number: 9734298
• Device Lot Number: 160816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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: 28 YR
• Patient Weight: 37