MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-TOTAL KNEE PACK

Catalog Number	DYNJ44008
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the blades fell off the handle into the surgical site.The procedure being performed was not identified.The blade was visually removed from the surgical site by the surgeon with an unidentified instrument.The reported product issue did not impact the patient's stability or the unidentified procedure.No serious injury, follow-up care, or medical intervention was reportedly required.No other patient, product, or procedural information was provided to the manufacturer.A sample was returned to the manufacturer for evaluation.The reported product issue was not confirmed.Due to the need for medical intervention to retrieve the blades from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the blades fell off the handle and into the surgical site.

• Common Device Name: DBD-TOTAL KNEE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7391798
• Report Number: 1423395-2018-00018
• Device Sequence Number: 13710843
• Product Code: OJH
• UDI-Device Identifier: 10888277079366
• UDI-Public: 10888277079366
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/03/2018

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?: No
• Operator of Device: Physician
• Device Catalogue Number: DYNJ44008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/03/2018
• 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