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

Model Number	ASMC
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report confirmed.Evaluation of the asmc confirmed the attachment tube, bearings, and bearing spacer were detached from the body of the attachment.The remainder of the attachment assembly was intact.It was noted all of the components of the attachment assembly were returned and present.Most of the heat cure epoxy that secures the tube to the base of the attachment was degraded.There was no record of service since june 2011.The likely cause for the tube detaching from the rest of the attachment assembly was due to the deterioration of the heat cure epoxy.The heat cure epoxy degrades over time.Once degraded, the epoxy tends to loosen with vibrations experienced during use and leads to the loosening of the tube from the base.A metal cutter attachment experiences high vibration and loads in normal use.The likely cause for the detachment of components is due to inadequate preventive maintenance which led to the degradation of the heat cure epoxy.The user manual contains the following warning ¿do not use a legend attachment if any part of the attachment appears to be bent, loose, missing, or damaged.¿ additional warning indicates ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.¿ the preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device had been in use for approximately 68 months with no record of factory service during this period.We will continue to track and trend this complaint type.
Event or Problem Description
It was reported that the attachment broke during the surgery, and a postoperative scan was required.It was reported there was no injury to the patient.Multiple attempts to obtain additional information, including the results of the scan, and patient status were unsuccessful.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MIDAS REX® LEGEND METAL CUTTER ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 6531876
• Report Number: 1625507-2017-00019
• Device Sequence Number: 16162864
• Product Code: HBB
• UDI-Device Identifier: 00613994418814
• UDI-Public: 00613994418814
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASMC
• Device Catalogue Number: ASMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention