MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; BLADE IN KNEE ARTHROSCOPY PACK

Catalog Number DYNJCH201

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

The blade slipped off the knife handle as the surgeon made an incision and fell into the surgical site.Several attempts were made to remove the blade.The blade was successfully removed with a pair of hemostats.The surgical tech attempted to reattach the retrieved blade to the handle.At this time it was noted the handle to hold the blade was broken.A second blade was readily available and the procedure was completed without further incident.Sample was returned and blade was broken in front of slot used for the bayonet mount for the handle.The root cause for the blade breaking is not known.The handle is not a medline device.The handle was not returned for investigation.In an abundance of caution this medwatch is being filed.

Event Description

A blade fell into a patient's surgical site during a knee operation.

• Type of Device: BLADE IN KNEE ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8477703962
• MDR Report Key: 6173291
• MDR Text Key: 62332863
• Report Number: 1423395-2016-00051
• Device Sequence Number: 1
• Product Code: OJH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJCH201
• Device Lot Number: 16IB3193
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 81