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

Model Number N/A

Device Problems Fracture (1260); Device Inoperable (1663)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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 was reported the elevators are broken.More information was requested and has yet to be received.

Manufacturer Narrative

The device was received for evaluation june 9, 2017.A follow-up report will be sent upon completion of the device evaluation.A second elevator was received that is from a different lot, therefore another report will be submitted.This is report one of two for the same event, reference report 0001032347-2017-00501.

Event Description

(in addition to what was already reported): it was confirmed that the event occurred during a procedure.The surgeon was able to retrieve all broken pieces from the patient.There was no delay to the procedure.The procedure was completed using another elevator.

Manufacturer Narrative

Two elevators #301 were returned without packaging.The elevators were visually evaluated and the tip was found to have been broken off on both instruments.There are scratches and normal signs of wear indicating the use of the instruments; no discoloration was observed.The complaint was confirmed as the instrument tip was broken off on both instruments.The most likely cause of the fracture was determined to be excessive force by the user.The instructions for use for this product 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.¿ the non-conformance database was reviewed and there was not a non-conformance found.There are no indications of manufacturing defects.This is report one of two for the same event; report two of two is reported on mfr #0001032347-2017-00501-1.

• Brand Name: ELEVATOR, SURGICAL, DENTAL
• Type of Device: DENTAL HAND INSTRUMENT, ELEVATOR #301
• 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: 6567369
• MDR Text Key: 75176479
• Report Number: 0001032347-2017-00391
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2017

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: 09-0257
• Device Lot Number: 011014A14
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: Not provided; 07/27/2017
• Supplement Dates FDA Received: 06/14/2017; 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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