MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734300

Device Problem Complete Blockage (1094)

Patient Problems Tissue Damage (2104); Injury (2348); Reaction (2414)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

Demographic information of the individual who got stuck during this event was not provided by the site.No patient was involved.Device lot # was not provided by the site representative and the instrument has not been returned.Therefore, lot # and device mfg date are not available as the mfg is dependant on knowing the lot #.The tap has not been returned for evaluation.The site was provided with the field correction notification and updated instructions for use which instruct the user not to use clogged taps or attempt to clean them with a wire.This device is included in the medical device field correction notification, "potential for user injury ¿ medtronic navigated cannulated taps" ((b)(6) 2015).The revised instructions for use (ifu) were also provided with the notification.

Event Description

A site sterile processing departement (spd) representative reported that there were multiple spine instruments involved in a quick turn and during the cleaning process the staff member was handed a k-wire to remove bone from a cannulated tap.The staff member poked their finger from this incident while trying to clean the tap out.The staff member was developing a fever after this incident.Site rep was unable to provide further details.

• Brand Name: 5.5MM 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5908220
• MDR Text Key: 53275906
• Report Number: 1723170-2016-03130
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 9734300
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1847-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other