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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (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 that an elevator that fractured during surgery.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

This follow-up report is being submitted to relay additional information.The complaint was opened because the facility reported the tip of the instrument broke during surgery.The modified beck elevator (part# sp-2359, lot# 091917i17) was returned for investigation.Visual evaluation showed signs of use as there were minor scratches on the body of the elevator and the tip had fractured off.The complaint is confirmed.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.The dhr was reviewed and there are no indications of a manufacturing defects.This is a level one complaint in accordance with the levels defined in sop 14.0.9 product evaluation section 7.2.3.The application fmea (see general instrument afmea) has been reviewed and it was determined that the reported event is identified in line# 9 \ use of instrument \ use of general instrument \ fracture, bend, twist, deform, or jams \ customer dissatisfaction, no replacement parts are available, major delay in surgery.The risk has a listed severity of 3 (referring to sop 4.1.1, modification to surgical procedure, major increase in surgical time) and occurrence of 2 (referring to sop 4.1.1, = 3%).Complaint history for (b)(4), lot# 091917i17 was reviewed, which leads to a complaint rate of 2.7%, which is no greater than the occurrence listed in the application fmea.The dhr was reviewed and there are no indications of a manufacturing defects.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: MODIFIED BECK ELEVATOR
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8986801
• MDR Text Key: 158638358
• Report Number: 0001032347-2019-00412
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/30/2019

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: SP-2359
• Device Lot Number: 100118I18
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 11/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1