MAUDE Adverse Event Report: ACUMED, LLC RIBLOC LOW PROFILE GUIDE ASSEMBLY ; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	RBL2520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon had finished putting the plate in the patient, when removing the low-profile primary guides from the plate, a small metal fragment broke off.The primary guide and broken metal fragments removed from patient and procedure completed without issue.
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.
Additional Manufacturer Narrative
The returned product was inspected under magnification.Under magnification the batch number of ribloc low profile guide assembly was confirmed.On the guide, the rlpg adjustment screw was fractured at an angle starting near where the screw head is nestled into the rlpg body and angling down towards the back of the guide.There are some scratches on the surfaces of the guide but not the other, no other observable signs of significant wear were noted.The fracture surfaces appears to be brittle, with a uniform dull, rough texture suggesting that this was a single overloading event rather than a series of fatiguing events.It is possible that the guide was overloaded during removal, however, no definitive conclusion can be made.Based on the investigation detailed above, no corrective action is warranted.Quality will continue to monitor for trends.

• Brand Name: RIBLOC LOW PROFILE GUIDE ASSEMBLY
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 23384495
• Report Number: 3025141-2025-00613
• Device Sequence Number: 15715069
• Product Code: HWE
• UDI-Device Identifier: 10806378123320
• UDI-Public: 10806378123320
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: RBL2520
• Device Catalogue Number: RBL2520
• Device Lot Number: 595623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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
• Patient Sex: Unknown