MAUDE Adverse Event Report: BIOMET MICROFIXATION HEIDBRINK ELEVATOR #2, ANGLED RIGHT; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tip of the instrument broke during surgery.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.The complaint is confirmed.A visual inspection was conducted on the elevator.The elevator shows heavy signs of wear.Further inspection shows that the tip has fractured.The non-conformance database was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to an instrument fracture for a 09-0340 lot 209610.The most likely underlying cause of the fracture is the application of excessive force beyond what the product is 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.

Event Description

It was reported the tip of the instrument broke while removing a tooth root tip.The fractured piece of the instrument was removed from the patient with suction.The procedure was completed with a back-up instrument.No adverse events have been reported as a result of the malfunction.

• Brand Name: HEIDBRINK ELEVATOR #2, ANGLED RIGHT
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10687174
• MDR Text Key: 211656570
• Report Number: 0001032347-2020-00514
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028855
• UDI-Public: 00841036028855
• 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,Followup
• Report Date: 11/05/2020

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: 09-0340
• Device Lot Number: 209610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 10/28/2020
• Supplement Dates FDA Received: 10/28/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1