MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE RENEWAL; 72203013 @PLATINUM, INCISORPLS BLADE

Model Number	REP112994
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a device got stuck in the patient's knee mid surgery and required removal.A new blade was opened to finish the procedure.The patient was reportedly undergoing a left knee scope and during the procedure the blade broke requiring the surgeon to manually remove the blade by hand.The surgeon opened another shaver and completed the procedure without further incident.No serious injury or follow up medical care was reported related to the customer reported issue.No additional medication was required as a result of the reported incident.There was no report of any adverse patient consequence, no effect on the patient's stability, and no medical intervention required as a result of the incident.No additional information is available.Due to the reported issue and in an abundance of caution this is an mdr reportable event.The actual sample was returned to for evaluation however a root cause could not be determined.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that a device got stuck in the patient's knee mid surgery and required removal.A new blade was opened to finish the procedure without further incident.

• Brand Name: MEDLINE RENEWAL
• Common Device Name: 72203013 @PLATINUM, INCISORPLS BLADE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10421267
• Report Number: 3032391-2020-00005
• Device Sequence Number: 16879738
• Product Code: HAB
• UDI-Device Identifier: 10888277354692
• UDI-Public: 10888277354692
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: REP112994
• Device Catalogue Number: 72203013RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98