MAUDE Adverse Event Report: ACUMED LLC 1.5MM HEX DRIVER TIP, LOCKING GROOVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	80-0728
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not returned for evaluation.As there was no return or confirmation of a batch number, acumed is unable to determine the revision.Acumed has previously established a the root cause through acumed's health hazard evaluation process.Additional reporting on this event will be provided as a follow up report if alternative information becomes available.
Event or Problem Description
It was reported: snapped 1.5 mm hex driver in 2.3 mm screw in aculoc2 plate.Driver tip snapped off when turning screw final time to lock into plate, was easily removed with forceps from screw head.

• Brand Name: 1.5MM HEX DRIVER TIP, LOCKING GROOVE
• 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 ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 25739749
• Report Number: 3025141-2026-00348
• Device Sequence Number: 18779959
• Product Code: LXH
• UDI-Device Identifier: 10806378044311
• UDI-Public: 10806378044311
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: 80-0728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 2.3 MM SCREW; UNKNOWN ACULOC 2 PLATE
• Patient Sex: Unknown