MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT LONG FLEX DRILL BIT

Catalog Number 916036

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2015

Event Type  Injury  

Event Description

This is a (b)(6) female that was scheduled for an elective right arthroscopy on 03/11/2015.During the procedure, the surgeon used a single use disposable drill bit for an anchor into the right hip bone and the drill bit broke.The surgeon was able to easily retreive the broke pieces with a grasper and placed the pieces into a sterile specimen cup.There is no injury to the patient.

• Brand Name: JUGGERKNOT LONG FLEX DRILL BIT
• Type of Device: JUGGERKNOT LONG FLEX DRILL BIT
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; warsaw IN 45682
• MDR Report Key: 4643393
• MDR Text Key: 5613954
• Report Number: MW5041686
• Device Sequence Number: 1
• Product Code: DZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Catalogue Number: 916036
• Device Lot Number: 827360
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 51