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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2019

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 instrument fractured outside of surgery.There was no patient involvement.

Event Description

It was reported that the instrument fractured during surgery.The broken piece of the instrument was removed from the patient.No adverse events have been reported, as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was initially reported that the instrument fracture did not occur during surgery.It was later discovered that the instrument fracture did occur during surgery.The name of the surgeon and date of surgery was also reported during a follow up.

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 tip broke off.The modified beck elevator (part# sp-2359, lot#100118i18 ) was returned for investigation.Visual evaluation showed signs of use as there was minor scratching 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.There are no indications of manufacturing defects.This is the only complaint for part# sp-2359, lot#100118i18.The dhr was reviewed and there are no indications of a manufacturing defects and there are no updates to the risk documents needed.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.

Event Description

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

• Brand Name: MODIFIED BECK ELEVATOR
• Type of Device: SURGICAL, DENTAL, ELEVATOR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9120755
• MDR Text Key: 160194782
• Report Number: 0001032347-2019-00423
• 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,Followup
• Report Date: 12/17/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 12/09/2019
• Supplement Dates FDA Received: 10/23/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1