MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tip of the elevator fractured during a procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The elevator #301 (part# 09-0257, lot# 071316f16) was visually evaluated.The elevator showed signs of moderate use with scratches on the handle.It was also clear that the distal end was fractured.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the instrument experienced excessive force, beyond what it was designed to encounter.The instructions for use (ifu) for this instrument states in the section titled warnings and precautions: the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip.If excessive pressure is applied to the tip of the instrument, it will bend, rendering it useless.This elevator is not intended for use when removing a tooth that is not loose in the socket.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: ELEVATOR #301
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8071189
• MDR Text Key: 127558524
• Report Number: 0001032347-2018-00786
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0257
• Device Lot Number: 071316F16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1