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

Model Number 9560565

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528); Component Missing (2306)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

Surgeon was using pituitary ronguer for spine surgery and piece of the cup of the rongeur broke off.He/she used a small pituitary to grasp and remove the fragment.A nerve hook was used to pull additional loose fragments free to be grabbed with the pituitary.Surgeon also used the pituitary to enter the disc space to grasp for loose fragments.Unfortunately, the micropituitary was noted to be broken and missing its inferior arm after the first pass.C arm imaging confirmed that it remained within the disc space.Surgeon tried to pull the fragment into the field with a nerve hook and also tried to grasp it with the biopsy grabber, using c arm to try to localize it.Surgeon was not able to remove it and determined after several minutes that they would cause damage with further manipulation and potential for nerve injury with continued retraction.This would be likely worse than the potential problems with this retained piece deep within the disc space.

• Type of Device: RONGEUR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; memphis TN 38118
• MDR Report Key: 4206213
• MDR Text Key: 5154191
• Report Number: 4206213
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2014

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 Model Number: 9560565
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2014
• Patient Sequence Number: 1
• Patient Age: 69 YR