MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX PNEUMATIC MOTOR; MOTOR, DRILL, PNEUMATIC

Model Number	PM700
Health Effect - Clinical Codes	Acoustic Trauma (1694); Hearing Impairment (1881)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been returned and currently under evaluation.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.Country of facility: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the motor connection was tested prior to surgery and the motor was functioning correctly.When the surgical process begins, and the motor was activated, a very loud noise is heard and the hand piece fell out of the surgeon's hand.It was reported there was no patient impact however three users of the equipment experienced acoustic trauma and are currently being evaluated by a doctor.No further information was available on follow up regarding the user's current condition.
Additional Manufacturer Narrative
Report confirmed.The product was returned with the motor body assembly detached from the knuckle/hose assembly.Some of the components were missing/not returned.An analysis was performed with the returned components and it showed that a potential cause for the detachment of the motor body from the knuckle assembly may have been the result of a manufacturing variance.Device history record 211558157 review was performed and no anomalies were identified.Ncmr 200233359 has been initiated to look into this further.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On further follow up it was reported that one of the device user may have experienced up to 20% loss of hearing.No other information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MIDAS REX PNEUMATIC MOTOR
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 7741300
• Report Number: 1625507-2018-00041
• Device Sequence Number: 1365783
• Product Code: HBB
• UDI-Device Identifier: 00643169672499
• UDI-Public: 00643169672499
• Combination Product (Y/N): N
• PMA/510(K) Number: K090112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: PM700
• Device Catalogue Number: PM700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/08/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/31/2018; 10/02/2018
• 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: Other
• Patient Age: 56 YR
• Patient Weight: 68