MAUDE Adverse Event Report: BIOMET 3I; SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

It was reported an unknown biomet loosened screw.Tooth location 47.

Manufacturer Narrative

The unknown biomet screw was not returned for investigation.Since product has not been returned, visual/functional inspection could not be performed.The product complaint evaluation # (b)(4).Investigation has been performed based on the available information using the item # and lot # (dhr/ifu/rmf).The reported event could not be recreated due to the nature of the dental device and event (loosening) and the complaint is related to the functional performance of the device.No pre-existing conditions were noted on the per.Pictures or x-ray images were not provided.Dhr review and complaint history review could not be performed, as item and lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.May post market trending was reviewed and there were no negative trends or corrective actions for the reported event (screw loosening) or devices (unknown biomet screw).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.A definitive cause could not be identified.The following sections have been updated: date of this report, date received by manufacturer, checked "follow-up," checked follow-up type, entered evaluation codes, added manufacturer narrative.

Event Description

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

• Type of Device: 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 8685191
• MDR Text Key: 147723226
• Report Number: 0001038806-2019-00495
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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