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	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device has not returned for evaluation.The root cause has been established through acumed's health hazard evaluation process.Acumed is taking appropriate actions to address this root cause.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 that during the procedure, they experienced breakage of the screwdriver tip.The tip of the screwdriver broke and remained stuck in the screw, and remains in situ.

• 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 ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24674746
• Report Number: 3025141-2026-00248
• Device Sequence Number: 10215498
• Product Code: LXH
• UDI-Device Identifier: 10806378044311
• UDI-Public: 10806378044311
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 80-0728
• Device Catalogue Number: 80-0728
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown