MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL BLADE IN TOTAL KNEE PACK

Catalog Number	DYNJ37469C
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a total knee procedure, a #10 surgical blade (taken from total knee pack) broke in half.At the time of the incident, the patient's leg was in flex position, and the femoral component had just been placed.Reportedly, the unused #10 surgical blade was handed to the surgeon to release the medial ligament and when the surgeon started to make his incision, the blade broke in half.It was denied that excessive force was applied to or against the blade.Per report, all pieces of the blade were successfully retrieved and the surgical site was irrigated with two bottles of irrisept (jet lavage containing low concentration chlorhexidine gluconate 0.05% in sterile water) and 3000 ml of saline.No impact to the patient, the staff, or the procedure was reported.There was no serious injury or follow-up care reported related to the event.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported event and required medical intervention, this medwatch is being filed.The sample was returned for evaluation and the reported issue of blade breaking in half was confirmed.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the surgical blade broke in half.The blade was successfully retrieved and irrigation of the surgical site was required.

• Common Device Name: SURGICAL BLADE IN TOTAL KNEE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8429300
• Report Number: 1423395-2019-00005
• Device Sequence Number: 1664578
• Product Code: OJH
• UDI-Device Identifier: 10889942761562
• UDI-Public: 10889942761562
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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 Catalogue Number: DYNJ37469C
• Device Lot Number: 18KBM925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention