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

Catalog Number DYNJ44008

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  Injury  

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 Description

It was reported that the blades fell off the handle and into the surgical site.

• Type of Device: DBD-TOTAL KNEE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7391798
• MDR Text Key: 104158577
• Report Number: 1423395-2018-00018
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10888277079366
• UDI-Public: 10888277079366
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ44008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention