MAUDE Adverse Event Report: DFINE INC. STABILIT COMPLETE FIRST FRACTURE KIT

Catalog Number 3353

Device Problems Bent (1059); Difficult to Remove (1528); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

Per received report: stabilit introducer got stuck in the bone after drilling down the first hand drill.The handle of the introducer made a clicking sound and rotated but the cannula did not rotate.The introducer was removed by hand.In addition, the activation element (ae) would not work.A new ae cable and hand switch were tried before replacing it.The introducer was removed and an on-control drill was used to access the pedical and drill into the vertebral body.A new stabilit introducer was placed and a new ae was used to successfully complete the procedure.There was no patient injury reported.

Manufacturer Narrative

The product has not been received within our facility for evaluation.Upon receipt, final evaluation will be conducted and a supplemental report will be filed accordingly.

Manufacturer Narrative

The customer reported issue of the stabilit introducer "getting stuck in the bone after drilling" was confirmed.The slight bend at the distal portion of the stylet confirmed that the unit encountered a dense bone.This is consistent with the damage caused when the unit encountered a hard bone.Although there was no apparent damage noted on the introducer and was safely withdrawn, the use of an on-control drill (manufactured by another company) to access the pedical and drilled into the vertebral body was an indication that the bone may have been sclerotic.This may have been the probable cause of the introducer to get stuck and prevented the cannula from rotating as stated in the report.Per ifu 1523, warning #5: "do not use this product in dense bone; device damage resulting in patient injury may occur.Breakage of the device may require intervention or retrieval".The activation element was not returned for evaluation and therefore, a physical investigation could not be performed to determine the cause of the issue.Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined.All units are 100% visually inspected and tested for its functionality during the manufacturing process.Additionally, a sampling of units is destructively tested to verify the stabilit introducer's integrity.

• Brand Name: STABILIT COMPLETE FIRST FRACTURE KIT
• Manufacturer (Section D): DFINE INC.; 3047 orchard parkway; san jose CA 95134 0000
• Manufacturer Contact: dan balbierz ; 3047 orchard parkway; san jose, CA 95134-0000
• MDR Report Key: 4964034
• MDR Text Key: 6321185
• Report Number: 3006396387-2015-00009
• Device Sequence Number: 1
• Product Code: GFI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2015

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 3353
• Device Lot Number: 150601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1