MAUDE Adverse Event Report: BIOMET 3I CERTAIN® TITANIUM HEXED SCREW; ABUTMENT SCREW

Catalog Number IUNIHT

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the abutment screw (iuniht) fractured.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Certain® gold-tite® hexed screws (iunihg) was returned for investigation.Visual inspection of the as returned product identified fracture confirmed on the threaded portions of screws.Therefore, based on the evaluation, device malfunction did occur and the reported event was confirmed following inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.A singular root cause could not be determined.

• Brand Name: CERTAIN® TITANIUM HEXED SCREW
• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8206978
• MDR Text Key: 131761995
• Report Number: 0001038806-2018-01068
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• 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: 12/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 98