MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #77R; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

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 the instrument fractured at the tip during an extraction procedure approximately five weeks ago.It was reported that there was no patient injury and the surgical delay was less than five minutes while the fractured piece was retrieved.The procedure was completed with another elevator.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The elevator was returned for investigation.The elevator was visually evaluated and found to show signs of use, with some minor scratching on the handle and a fractured tip.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied, 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.

Event Description

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

• Brand Name: ELEVATOR #77R
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8598843
• MDR Text Key: 144688044
• Report Number: 0001032347-2019-00273
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028657
• UDI-Public: 00841036028657
• 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: 07/15/2019

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: 09-0313
• Device Lot Number: 120417K17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1