MAUDE Adverse Event Report: Medline ReNewal MEDLINE; 72200095 @INCISOR PLS ELITE (WHITE) 3.5M

Catalog Number	72200095RH
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device ¿came apart when taking it out of patient¿.
Additional Manufacturer Narrative
According to the customer, when using the incisor blade for a ¿knee scope¿, it broke¿ during the case; the customer reported there was no impact to the patient and no medical intervention or serious injury related to the reported incident.During the investigation, the received device was inspected for nonconformities per internal procedure, and it was observed that the device shaft had completely separated from the hub and cracking was observed on the outer hub where the outer shaft is secured to the device.The reported issue was confirmed.The exact root cause of the damaged device could not be determined; however, a potential root cause of the damaged device/hub was due to side-load being applied to the device during use.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: 72200095 @INCISOR PLS ELITE (WHITE) 3.5M
• 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: 50854002
• Report Number: 3032391-2026-00134
• Device Sequence Number: 18655319
• Product Code: HRX
• UDI-Device Identifier: 10888277387836
• UDI-Public: 10888277387836
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/21/2026

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: 72200095RH
• Device Lot Number: 431399
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2023
• 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: 01/11/2023
• Initial Report FDA Received Date: 09/22/2026
• 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