MAUDE Adverse Event Report: Medline ReNewal MEDLINE RENEWAL; FORMULA RESECTOR CUTTER 4.0MM

Catalog Number	375542000RH
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when being plugged in - reading expired.".
Additional Manufacturer Narrative
The reported issue was: "when being plugged in - reading expired." the device was returned for evaluation, the medline renewal package was returned with the device, visual nonconformities were not observed, and the device was not tested for functional defects.The reported issue was confirmed; it was determined through the reported issue that the received device is no longer compatible with the customer¿s console.The root cause of the issue was possibly due to the 1.0.5 (or later) software update for the stryker crossfire/crossfire ii console, and the conclusion was that this was a customer knowledge error and not a mistake by medline renewal because reprocessed medline renewal stryker shavers are only compatible with software version 1.0.04 (or below), which is indicated on the device label.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE RENEWAL
• Common Device Name: FORMULA RESECTOR CUTTER 4.0MM
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond OR 94456 -187
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50872207
• Report Number: 3032391-2026-00151
• Device Sequence Number: 21160699
• Product Code: HRX
• UDI-Device Identifier: 10888277379923
• UDI-Public: 10888277379923
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Device Catalogue Number: 375542000RH
• Device Lot Number: 488718
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown