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

Model Number	AS14-R
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the surgeon started drilling, the drill was making terrible noise.The scrub technician examined the attachment and found that the ball bearings were missing.It was reported that there was a procedure delay for the patient to undergo an x-ray which was read as negative and confirmed that there was no device debris left inside the patient's body.It was also reported that the patient has no injury.

• Brand Name: LEGEND STRAIGHT 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: 7851945
• Report Number: 1625507-2018-00049
• Device Sequence Number: 2347597
• Product Code: HBB
• UDI-Device Identifier: 00613994421890
• UDI-Public: 00613994421890
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: AS14-R
• Device Catalogue Number: AS14-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/06/2018
• 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 Weight: 67