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	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon noticed the broken driver on the postoperative x-ray.The surgery to remove the broken driver tip was performed 8 days later.
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.Related report (including this one): 3025141-2026-00076.
Additional Manufacturer Narrative
The returned product was inspected under magnification.Under magnification the batch number of the 1.5mm cann.Quick release driver tip was confirmed.It was observed that the returned driver had a broken tip with the broken fragment returned as well.The fracture surface on both the driver tip and the returned fragment shows clear indications of torsional failure, with a twisting fracture surface.The driver was measured to approximate the fracture location.This fracture pattern may be present when drivers have excess force applied to them to overcome heightened resistance such as that which occurs due to dense bone or inadequate pilot hole depths.No definitive cause can be determined.Related report (including this one): 3025141-2026-00075, 3025141-2026-00076.

• 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
• 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: 24328625
• Report Number: 3025141-2026-00075
• Device Sequence Number: 9674830
• Product Code: LXH
• UDI-Device Identifier: 10806378070198
• UDI-Public: 10806378070198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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?: 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: 236517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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 Sex: Unknown