MAUDE Adverse Event Report: ACUMED LLC T6 CANNULATED HEXALOBE DRIVER; DRIVER, PROSTHESIS

Model Number	80-4149
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via a text generated voicemail: "hey, and remind name is (b)(6).I am out in (b)(6) with (b)(6).We have broken 2 of the canned nano driver tips, 80414 901 broke off today and affected the case.He was doing a perk skateboard, a 2 screw skateboard, and broke it on the second screw, and had to open it.So i need to get an r to send back this driver tip so you guys can look at it.And i think i will have a card.I will call the dr.So just so you know, i need to file a register a complaint on a broken driver slip again, the part numbers 804149 and get an r to send that driver tip back (b)(6).Thanks, (b)(6).".
Additional Manufacturer Narrative
No product has been received to date.If product is returned, an examination will be performed and its findings will be send at as follow up.

• Brand Name: T6 CANNULATED HEXALOBE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: aram tran ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24653785
• Report Number: 3025141-2026-00207
• Device Sequence Number: 5676868
• Product Code: HWR
• UDI-Device Identifier: 10806378121609
• UDI-Public: 10806378121609
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 Number: 80-4149
• Device Catalogue Number: 80-4149
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown