MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONIC MICRO PITUITARY RONGEUR

Model Number 9569567C

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2019

Event Type  malfunction  

Event Description

Retained foreign object.During an open left l4-5 and l5-s1 hemilaminectomy, medial facetectomy and microdiscectomy, the medtronic micro pituitary rongeur (black, size 2mm, prod #9569567c) broke inside the pt.One of the "jaws" broke off in the l5-s1 disc space.Attempts were made to retrieve it but were unsuccessful.The determination was to leave it in as more attempts would likely cause more harm than benefit.The instrument was sequestered and we have it available for inspection.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC MICRO PITUITARY RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 8935806
• MDR Text Key: 155977560
• Report Number: MW5089351
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9569567C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 87