MAUDE Adverse Event Report: Medline ReNewal MEDLINE; 72200728 @ELITE STONECTR BUR, (MAROON/YE

Catalog Number	72200728RH
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "doctor was using burr at highest speed and said he felt like it was not cutting the bone as efficiently as the oem.Compared it to using a butter knife.".
Additional Manufacturer Narrative
The customer reported that the doctor was using the burr at highest speed and felt it was not cutting the bone as efficiently as the oem, comparing it to using a butter knife.During the investigation, the received device was microscopically inspected for nonconformities per internal procedure, and it was observed that there was damage to the tip of the burr; it was slightly chipped and observed to be dull.The reported issue was confirmed, and the exact root cause could not be determined; a potential root cause of the reported issue was due to damage sustained during use.No report of any patient injury or adverse event was received.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
• Common Device Name: 72200728 @ELITE STONECTR BUR, (MAROON/YE
• 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: 50804972
• Report Number: 3032391-2026-00107
• Device Sequence Number: 15616527
• Product Code: HRX
• UDI-Device Identifier: 10888277388550
• UDI-Public: 10888277388550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/17/2026

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: 72200728RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2023
• 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: 02/16/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (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