MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MAJOR ORTHOPEDIC PACK

Catalog Number	DYNJ41393C
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that approximately on (b)(6) 2018, the blade broke off the handle and fell into the patient's knee during a total knee arthroplasty requiring visual retrieval by surgeon.It was reported that the product was inspected prior to use and the issue was not identified at that time.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No additional information was provided related to the reported incident.The condition of the device is not known.A root cause has not been determined.No additional information is available.A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the blade broke off of the handle and fell into the patient's knee.

• Common Device Name: MAJOR ORTHOPEDIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7300359
• Report Number: 1423395-2018-00007
• Device Sequence Number: 1342370
• Product Code: OJH
• UDI-Device Identifier: 10888277937192
• UDI-Public: 10888277937192
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/27/2018

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: Physician
• Device Catalogue Number: DYNJ41393C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/27/2018
• 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