MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #77R; 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	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the instrument fractured during surgery.The procedure was completed with a back-up instrument.No adverse events were reported as a result of the malfunction.
Event or Problem Description
New information was received that this event is a duplicate to a previously reported complaint.Complaint is a duplicate to (b)(4) and reported in medwatch 0001032347-2020-00082.
Additional Manufacturer Narrative
Complaint is a duplicate to (b)(4) and reported in medwatch 0001032347-2020-00082.

• Brand Name: ELEVATOR #77R
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9949783
• Report Number: 0001032347-2020-00214
• Device Sequence Number: 3257743
• Product Code: EMJ
• UDI-Device Identifier: 00841036028657
• UDI-Public: 00841036028657
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 09-0313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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