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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 an elevator fractured during surgery.The procedure was completed with another instrument.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.Functional testing could not be performed due to the product not being returned.The customer provided picture does clearly show that the elevator end tip has fractured.The dhr and occurrence rate of this lot will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (09-0313) and the previous one year (from the notification date) regarding the tip fracturing, (b)(4), which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is excessive force beyond what the product is designed to take.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
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9661921
• Report Number: 0001032347-2020-00082
• Device Sequence Number: 3474719
• 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: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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