MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #0; ELEVATOR, SURGICAL, DENTAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported the tip of the instrument fractured during a procedure resulting in a 30 minute delay due to an x-ray being taken to search for fractured pieces.No fractured pieces of the instrument were found in the patient.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual evaluation showed signs of use as there was minor scratching on the body of the elevator.Further evaluation showed that the tip had fractured off.The dhr 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 09-0258 lot 100516i16.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was 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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: ELEVATOR #0
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10784364
• Report Number: 0001032347-2020-00552
• Device Sequence Number: 3645367
• Product Code: EMJ
• UDI-Device Identifier: 00841036028190
• UDI-Public: 00841036028190
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0258
• Device Lot Number: 100516I16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1