MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND METAL CUTTER ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number ASMC

Device Problems Misconnection (1399); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

Report confirmed.Evaluation of the attachment determined it could not be driven by a motor, and could not be installed on a motor.On disassembly it was noted the attachment drive shaft was deformed; there was a groove worn entirely around the attachment shaft.This prevented the attachment from interfacing properly with the motor shaft.It was also noted the shaft was discolored.In addition, a collet pin was lodged in the pilot hole of the attachment input shaft.Evaluation of the motor determined it would not lock an attachment.The motor was disassembled and the components were in good condition with no abnormal wear.On examination of the motor collet shaft, it was noted the pin was sheared off.This was the pin which was inside the attachment.It is likely the attachment drive shaft was damaged during use in a different motor.The damaged attachment drive shaft caused shearing of the motor pin of the returned motor.When placed into the motor, the groove in the drive shaft prevented the ball bearings from driving the attachment shaft.As a result, the motor pin was likely driving the attachment shaft, and consequently the tool.Once the tool was placed under load or torque the motor pin was sheared.With the pin broken the rotation stopped.The cause of groove damage to the attachment drive shaft could not be determined.However, it was determined the damage to the shaft occurred prior to this procedure.We are reporting this event to fda due to the surgeon¿s decision to schedule a second surgery to complete the surgical procedure.The user manual contains the following warning ¿do not use legend system components if damage is apparent or if components do not run properly.The legend system must be inspected for damage prior to each use.¿ we will continue to track and trend this complaint type.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to the sales representative that the pneumatic motor (pm100) would not turn the metal cutting attachment (asmc).The sales representative had attempted to troubleshoot with the surgeon over the phone.The asmc attachment was unable to lock onto two different motors because it could not be fully seated.The orthopedic surgeon was attempting to cut implanted metal in the patient when the metal cutting tool failed to turn in the drill.It was reported the procedure was discontinued due to the device issue.On follow up with the facility it was confirmed the procedure had been postponed and rescheduled for (b)(6) 2016.The surgeon had consulted the family prior to the decision.During the initial procedure the metal cutting tool was used, but had stopped functioning after approximately 5 seconds.The scheduled procedure was to remove a proximal end of a prominent femoral nail.The patient was on the operating table at the time of the event, and the surgeon had opened the surgical site when the event occurred.It was also confirmed the rescheduled procedure on (b)(6) 2016 was completed without issue, and the operation was a success.

• Brand Name: LEGEND METAL CUTTER ATTACHMENT
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: david leers ; 4620 north beach street; ft. worth, TX 76137-3291 ; 8177886587
• MDR Report Key: 5746444
• MDR Text Key: 48094450
• Report Number: 1625507-2016-00024
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASMC
• Device Catalogue Number: ASMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other