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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country - (b)(6).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 the elevator fractured during the extraction of a lower impacted wisdom tooth.The tooth was sectioned and after using another instrument to separate the tissue, the dentist attempted to use the elevator and it snapped "almost in half".There was no intervention required to remove the fractured instrument, no injury, and no delay in the case.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Product identity could not be confirmed due to the product not being returned.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are no indications of manufacturing defects.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.

• Brand Name: ELEVATOR #77R
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8067195
• MDR Text Key: 127111750
• Report Number: 0001032347-2018-00769
• Device Sequence Number: 1
• Product Code: EMJ
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1