MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2022-00078.

Event Description

It was reported that the elevator broke.There is no known impact or consequence to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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

Event Description

It was reported that the patient was in the office to have two teeth extracted with iv sedation, when elevator broke.The chipped fragment was retrieved with the suction.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4; d9; g3; g6; h1; h2; h3; h6; h10.A visual inspection was conducted on the returned elevators.Two of the returned elevators (qty one lot j21 and qty one lot i21) show signs of multiple uses including marking/ scratching on the product surfaces.The tips on both of these instruments have fractured.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ELEVATOR #301
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13694725
• MDR Text Key: 289329413
• Report Number: 0001032347-2022-00079
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028176
• UDI-Public: (01)00841036028176(10)T213000002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

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: 09-0257
• Device Lot Number: T213000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 06/24/2022
• Supplement Dates FDA Received: 03/15/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White