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

Model Number REP112994

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/23/2020

Event Type  Injury  

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 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
• Type of Device: 72203013 @PLATINUM, INCISORPLS BLADE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il
• MDR Report Key: 10421267
• MDR Text Key: 203359686
• Report Number: 3032391-2020-00005
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 10888277354692
• UDI-Public: 10888277354692
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98