MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PAK NEEDLE KIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9733498
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); Iatrogenic Source (2498)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field representative was available onsite when the reported event occurred.He confirmed that the disposable instrument broke inside of the patient's anatomy during surgery.The foreign body was surgically removed from the patient's anatomy.No patient health complications were reported by the site.Damaged instrument was not returned to manufacturer for analysis, therefore, no findings are possible.
Event or Problem Description
A medtronic representative reported that while in a spinal fusion procedure, the pak needle cannula broke off inside the patient.The surgeon drilled it out and was able to pull it from the patient.There was a reported delay to the procedure of less than 1 hour due to this issue.
Additional Manufacturer Narrative
Additional information: a medtronic representative reported that the damaged components were removed from the cannula by drilling out the pieces.It was reported that 1 to 1.5 inches of the instrument broke off.

• Brand Name: PAK NEEDLE KIT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6539118
• Report Number: 1723170-2017-01911
• Device Sequence Number: 13674305
• Product Code: OLO
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/16/2018
• Device Catalogue Number: 9733498
• Device Lot Number: 161116
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 218