MAUDE Adverse Event Report: ACUMED, LLC 1.5MM CANN. QUICK RELEASE DRIVER TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HT-0915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One 1.5mm cann.Quick release driver tip was returned broken.Only the main body portion of the driver was returned (tip portion not returned); evaluation will be for the main body.Driver was examined under magnification.Driver exhibits a jagged, multi-surface fracture region with surfaces sitting varying degrees obliquely to the device axis.Signs of fatigue are not present at the fracture site (e.G.Progression or "seashell" marks).A measurement of the overall returned body length was taken.No definitive conclusions can be made.
Event or Problem Description
It was reorted that a micro driver tip broke off in the screw head when putting in screw.The piece was extracted and another driver was used.A reported delay of 20 minutes with no adverse consequences to the patient.

• Brand Name: 1.5MM CANN. QUICK RELEASE DRIVER TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 24351644
• Report Number: 3025141-2026-00105
• Device Sequence Number: 17375245
• Product Code: LXH
• UDI-Device Identifier: 10806378070198
• UDI-Public: 10806378070198
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: HT-0915
• Device Catalogue Number: HT-0915
• Device Lot Number: 226808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White