MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #77R; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

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 Description

It was reported the elevator broke.An x-ray was performed to ensure removal of the broken piece; there was a delay of 16-30 minutes.No adverse events have been reported as a result of the malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The customer reported one elevator; however there were five (5) elevator #77r (part# 09-0313) returned.No response has been received at this time regarding the additional elevators.Two (2) of these were of lot 120417k17 and three (3) were of lot 042518d18.All of the elevators exhibited fractured tips.Device history records (dhrs) were reviewed and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the instruments 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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2019-00149.

• Brand Name: ELEVATOR #77R
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8071235
• MDR Text Key: 127558157
• Report Number: 0001032347-2018-00782
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0313
• Device Lot Number: 120417K17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1