MAUDE Adverse Event Report: ACUMED, LLC POLARUS® 3 CAP SCREW DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	80-1635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 reports (including this one): 3025141-2026-00039, 3025141-2026-00040.
Event or Problem Description
The distributor reported that "during the polarus 3 surgery, it seems he had some difficulty inserting the cap screw." no adverse effect, but a delay of 30 minutes.
Additional Manufacturer Narrative
The returned products were inspected under magnification.Under magnification the batch number of the polarus® 3 cap screw driver were confirmed.The batch number of the returned cap screw could not be confirmed as there is no direct part marking on the polarus® 3 cap screw 0mm due to space.There was visible damage to the threads of the cap screw, with the threads being flattened and deformed, possibly due to cross threading during insertion.The returned cap screw and driver were returned joined/assembled.On the driver, the shaft and hex area are in good shape with minor laser markings missing or faded from multiple reprocessing and use.No other observable damage is evident on the driver.The nail used was not returned to confirm failure.No definitive conclusion could be made.Based on the investigation detailed above, no corrective action is warranted.Quality will continue to monitor for trends.Related reports (including this one): 3025141-2026-00038, 3025141-2026-00039, 3025141-2026-00040.

• Brand Name: POLARUS® 3 CAP SCREW DRIVER
• 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: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24024434
• Report Number: 3025141-2026-00038
• Device Sequence Number: 10550266
• Product Code: LXH
• UDI-Device Identifier: 10806378050527
• UDI-Public: 10806378050527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 80-1635
• Device Catalogue Number: 80-1635
• Device Lot Number: 357932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/18/2026
• 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
• Patient Race: Asian