MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY; BLADE IN KNEE ARTHRO PACK

Catalog Number DYNJ0613548V

Device Problem Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

During a knee arthroscopy a bd manufactured blade fell into the surgical site.As the surgeon made the initial incision into the knee, the blade broke and was lodged in the patient's knee.The surgeon was able to remove the blade.The procedure increased from fifteen minutes to fifty-one minutes.The blade was returned to medline and the complaint of the blade being broken was confirmed.A root cause could not be determined.Bd the manufacturer has been informed and will do own investigation.

Event Description

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

• Type of Device: BLADE IN KNEE ARTHRO PACK
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417 1880
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6260964
• MDR Text Key: 65110340
• Report Number: 1423395-2016-00053
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ0613548V
• Device Lot Number: 16JK0172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: 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: 15 YR
• Patient Weight: 73