MAUDE Adverse Event Report: BIOMET 3I NARROW STANDARD LARGE HEXED DRIVER, 24MM

Catalog Number PHD03N

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned to manufacture.Product was swallowed by patient.

Event Description

It was reported that during a follow up appointment, while adjusting the cover screw, the patient moved, and the driver fell into the patient´s mouth directly.The patient swallowed the driver.The doctor called the patient to follow up and the patient is fine without pain or any discomfort.

Manufacturer Narrative

The product associated with this complaint was not returned.The complaint could not be verified.The lot number was not provided; therefore, a device history record review could not be completed.A definitive root cause has not been determined.

• Brand Name: NARROW STANDARD LARGE HEXED DRIVER, 24MM
• Type of Device: LARGE HEXED DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6842385
• MDR Text Key: 85008900
• Report Number: 0001038806-2017-00591
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: PHD03N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1