MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #0; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (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 that an instrument fractured during a dental procedure.The fractured piece of the instrument was removed from the patient by suction and the procedure was completed with a back-up instrument.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The complaint was opened because the facility reported the tip of the instrument broke off.The elevator #0 (09-0258, lot# 032613c13) was returned for investigation.Visual evaluation showed signs of use as there was minor scratching on the body of the elevator and the tip had fractured off.The non-conformance database was reviewed for this product, no non-conformances were found.Complaint history for 09-0258, lot# 032613c13 was reviewed and there is a complaint rate of 0.1%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem d4 lot number d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

Event Description

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

• Brand Name: ELEVATOR #0
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9330484
• MDR Text Key: 190362211
• Report Number: 0001032347-2019-00489
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028190
• UDI-Public: 00841036028190
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 09-0258
• Device Lot Number: 032613C13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1