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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).It is unknown at this time if the device will be returned for evaluation.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 instrument fractured.Attempts have been made and no further information has been provided.
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.The elevator #0 (p/n: (b)(4), lot# 071316f16, qty 2) were returned for investigation.Upon review of the elevators, it was noted that they had fractures at their respective tips.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.A complaint review was performed for this part and lot number combination and there is a failure rate of 4%.This rate is less than the afmea rate of 7%; therefore, this is considered acceptable and no further action will be taken.The most likely underlying cause of the complaint is that the elevator tips experienced force in excess of what they were 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.The following fields were updated: b4 date of this report b5 describe event or problem d4 lot number d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h4 device manufacturer date h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: ELEVATOR #0
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9841651
• Report Number: 0001032347-2020-00172
• Device Sequence Number: 2871510
• Product Code: EMJ
• UDI-Device Identifier: 00841036028190
• UDI-Public: 00841036028190
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 071316F16
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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