MAUDE Adverse Event Report: Highridge Medical, LLC PLUG DRIVER; Screwdriver

Catalog Number	2000-9061
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, while inserting the closure tops using a polaris plug driver, the closure tops were difficult to hold in place.The tip of the driver was determined to be twisted.There was no patient or procedural impact.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: PLUG DRIVER
• Common Device Name: Screwdriver
• Manufacturer (Section D): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; +1(303)501-8506
• MDR Report Key: 50482082
• Report Number: 3012447612-2026-00230
• Device Sequence Number: 10396151
• Product Code: HXX
• UDI-Device Identifier: 03662663191876
• UDI-Public: (01)03662663191876(10)ZB6752951
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: Exempt
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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 Catalogue Number: 2000-9061
• Device Lot Number: ZB6752951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown