MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #77R

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(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 an elevator fractured during an extraction procedure.The physician did not recall which tooth was extracted.He stated that the case went fine, but after the case, his assistant noted that the elevator was chipped at the tip.Therefore, he took an x-ray to confirm that no piece remained in the patient's mouth.The x-ray confirmed there was no foreign body.He indicated that he routinely irrigates and suctions thoroughly and believes that the piece was likely picked up during suction.There was no injury or delay in the procedure.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 confirmed by review of a photograph.Product identity could not be confirmed due to the part not being returned.Functional testing and inspections could not be performed due to the product not being returned.In the photograph provided by the surgeon, there is one elevator with a tip that is fractured; therefore, the complaint is confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to the instrument experienced force in excess of what it was designed to encounter.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
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8052754
• MDR Text Key: 126996955
• Report Number: 0001032347-2018-00750
• 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: 10/10/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1