MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #0

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Because the lot number is unknown, the device history records could not be pulled and reviewed.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It is reported that the instrument broke at the tip during a procedure.It is reported that no pieces were embedded in the patient's gums.It is reported the tip was visible and removed with suction.It is reported the event did not result in a delay in the procedure or a patient injury.It is reported the procedure was completed with another available instrument.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The product was returned without packaging.The elevator was visually evaluated and the tip was found to be broken off.The broken fragment was not returned with the elevator; therefore, the complaint is confirmed.There are scratches and normal signs of wear on the handle indicating the use of the instrument; no discoloration was found.A functional check was not performed as tip was not present.The most likely cause of the fracture was determined to be excessive force applied by the user.The instructions for use state in the section titled warnings and precautions: avoid undue stress or strain when handling or cleaning instruments.The nonconformance database was reviewed and no non-conformance was found.There are no indications of a manufacturing defect.

• Brand Name: ELEVATOR #0
• Type of Device: ELEVATOR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6297502
• MDR Text Key: 66425935
• Report Number: 0001032347-2017-00080
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0258
• Device Lot Number: 121812L12
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2017; 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention