MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; ELEVATOR, SURGICAL, DENTAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that the instrument broke during surgery.The fractured piece was recovered and no harm was done to the patient and no delay in surgery.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the terminal portion of the elevator fractured luxating interproximal at #1 and #2 teeth.The surgical technique was performed properly during the surgery.T was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination identified the device tip to be fractured.Scratches and other wear marks were noted.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MODIFIED BECK ELEVATOR
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12763405
• Report Number: 0001032347-2021-00525
• Device Sequence Number: 14312588
• Product Code: EMJ
• UDI-Device Identifier: 00841036285302
• UDI-Public: (01)00841036285302(10)T203180000
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: SP-2359
• Device Lot Number: T203180000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 02/22/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/22/2021; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Patient Sex: Unknown