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U.S. Department of Health and Human Services

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

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MDT POWERED SURGICAL SOLUTIONS LEGEND ANGLED ATTACHMENT; MOTOR, DRILL, PNEUMATIC Back to Search Results
Model Number AA10S
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/30/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that bearings are detached.The likely cause of failure was due to corrosion.It was also noted that the tool could not be inserted.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event or Problem Description
It was reported that the attachment parts fall off.It was reported there was no patient involvement.
 
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Brand Name
LEGEND ANGLED ATTACHMENT
Common Device Name
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
justin ellis
8200 coral sea street ne mvs21
mounds view, MN 55112
7635265677
MDR Report Key24398038
Report Number1625507-2026-00073
Device Sequence Number12817953
Product Code HBB
UDI-Device Identifier00763000440244
UDI-Public(01)00763000440244(11)220914
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K020069
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/19/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberAA10S
Device Catalogue NumberAA10S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2026
Initial Report FDA Received Date02/20/2026
Date Device Manufactured09/14/2022
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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