MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #2; 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)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while the doctor was luxating a tooth, the tip of the instrument fractured.The tip was easily suctioned out.No adverse events have been reports as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The elevator was in good overall condition, with some minor cosmetic damage from general handling and the tip was fractured.No additional complaints were found on this lot.The most likely underlying cause of the complaint is excessive force was applied, beyond what the instrument 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: ELEVATOR #2
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8735557
• Report Number: 0001032347-2019-00338
• Device Sequence Number: 16787154
• Product Code: EMJ
• UDI-Device Identifier: 00841036028220
• UDI-Public: 00841036028220
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0261
• Device Lot Number: 011014A14
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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