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

Catalog Number PHD03N

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: not provided (b)(4).Age at time of the event, date of birth not provided.Gender not provided.Patient weight not provided.Lot number not provided.

Event Description

Doctor reported that the phd03n tip (hex) that engages the screw snapped off during a laboratory procedure.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: p-iis086gi rev.F 11/2015 and instsm rev d 02/16.Information identified: pick-up and delivery of implant: care must be taken when inserting the implant placement driver tip into the implant.A very low rpm must be used as you approach the internal connection of the implant with the driver tip to properly align the internal hex of the implant with the external hex of the driver.Press down firmly to engage the implant securely.Complaint alleges the screw driver was fractured during use.Complaint is non-verifiable without return of the product.A root cause for this complaint could not be determined.

• Brand Name: NARROW STANDARD LARGE HEXED DRIVER, 24MM
• Type of Device: 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: 7133017
• MDR Text Key: 95745165
• Report Number: 0001038806-2017-00926
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: PHD03N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1