MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) AWL TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734404

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

A field representative reported that the tip of the awl tip instrument was bent, however, the part was not returned to manufacturer for analysis, therefore, no findings are possible.Replacement of the instrument resolved the issue.No further issues were reported.Part not returned.

Event Description

A medtronic representative reported that while in a spinal fusion procedure, they discovered a bent tip on the awl tip instrument.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

The hardware investigation of the returned awl tip found that the reported event was related to a physical damage issue.As reported, the tip of the awl was visibly bent.There are also impact marks at the back end of the instrument.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: AWL TIP
• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027 ; 7208902082
• MDR Report Key: 6409787
• MDR Text Key: 70110124
• Report Number: 1723170-2017-01232
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994736055
• UDI-Public: 00613994736055
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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 Catalogue Number: 9734404
• Device Lot Number: 150122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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