MAUDE Adverse Event Report: BIOMET 3I UNKNOWN; ABUTMENT SCREW

Catalog Number IUNIHT

Device Problems Fracture (1260); Application Program Problem (2880); Data Problem (3196)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The dentist reported a fractured screw.The dentist was not able to remove the fractured portion of the screw so they removed the implant.Due to loss of their data base, the clinic is unable to provide any information on the implant that was removed.

Manufacturer Narrative

The customer returned three screws for three different complaints.It is unknown which screw is associated with each complaint.One of the screws looks like (b)(4); the other screws do not appear to be (b)(4).The screws returned could potentially be a competitor screw as a review of the product catalog does not show a screw that matches the unknown screws.Visual inspection reveals that the screws have been in use.Examination reveals the portions of the fractured screws have been returned with the exception of one, which is stated to have been left in an unknown implant.The implant was not returned.The lot numbers for the screws and the lot number for the implant were not provided and therefore the device history record reviews could not be completed.A definitive root cause has not been determined.

• Brand Name: UNKNOWN
• Type of Device: ABUTMENT SCREW
• 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: 5212097
• MDR Text Key: 30832160
• Report Number: 0001038806-2015-00834
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: 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