MAUDE Adverse Event Report: INTERVENTIONAL SPINE, INC. PERPOS PLS SYSTEM; 2-IN-1 DRILL

Model Number 6070

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

It was reported that when the surgeon was drilling through the facet, the drill broke off into couple of pieces.The surgeon was not able to remove from the patient the broken drill pieces.

Manufacturer Narrative

A review of the lot history for this component indicates that it was manufactured to specifications and there were no non-conformances.The failure mode which causes this type of drill breakage is the user bending the drill while in the process of drilling.This results in drilling off-alignment with respect to the k-wire on which the drill is placed.The purpose of the k-wire is to provide a guided path for which the drill is to be advanced into the desired surgical area.In cases where the drill and k-wire are not kept aligned with respect to the longitudinal axes of both components, users may experience k-wire advancement, increasing friction, and k-wire bending.These issues are common in any over-the-wire orthopedic surgical procedure.Likewise, utilizing the drill when not in proper alignment with the k-wire may also lead to drill breakage due to high stress and friction created between the off-alignment drill and k-wire components.

• Brand Name: PERPOS PLS SYSTEM
• Type of Device: 2-IN-1 DRILL
• Manufacturer (Section D): INTERVENTIONAL SPINE, INC.; irvine CA
• Manufacturer Contact: 13700 alton pkwy., suite 160; irvine, CA 92618 ; 9494720006
• MDR Report Key: 4859175
• MDR Text Key: 5875727
• Report Number: 2032499-2015-00002
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6070
• Device Catalogue Number: 6070
• Device Lot Number: 022113B
• Other Device ID Number: 8119540103552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention