MAUDE Adverse Event Report: ACUMED, LLC 2.7MM X 13MM NL HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	3070-27013
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device has not returned for evaluation and has been reported to acumed that it will not be returned.The majority of the screw remains buried in the bone and the head of the screw was discarded.Acumed conducted a health hazard evaluation (hhe).The result of the hhe was to initiate a class ii recall, res#99123.
Event or Problem Description
It was reported that the surgeon tried using 2.7 nl screw in the radius while using dorsal spanning plate.Screw head with 1-2 threads broke in half, leaving majority of screw buried in bone with head handed to back table to be discarded.The procedure was completed with the sugeon continuing on with other screw holes.There was no reported delay in surgery.

• Brand Name: 2.7MM X 13MM NL HEXALOBE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 25480445
• Report Number: 3025141-2026-00300
• Device Sequence Number: 16082361
• Product Code: HWC
• UDI-Device Identifier: 10806378126048
• UDI-Public: 10806378126048
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K251132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 3070-27013
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES-99123
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DORSAL SPANNING PLATE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 77 KG