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

Model Number	AVA09
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/19/2021
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the secure ring to lock the drill bit was too tight to turn.It was reported that there was a 100-minute procedure delay.No patient impact reported.It was also reported that the device will not be returned.On follow-up, it was reported that the patient had a prolonged exposure to anesthesia due to the delay, however, it was confirmed that there was no patient impact.It was also reported that an additional action of excessive turning of the lock ring was performed.

• Brand Name: LEGEND ANGLED VAR 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: 12076784
• Report Number: 1625507-2021-00228
• Device Sequence Number: 19700272
• Product Code: HBB
• UDI-Device Identifier: 00763000084974
• UDI-Public: 00763000084974
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: AVA09
• Device Catalogue Number: AVA09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/28/2021
• 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