MAUDE Adverse Event Report: BIOMET 3I; DENTAL PLACEMENT TOOL

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Ifnt410, full osseotite tapered certain implant 4 x 10mm/ lot number: 2017041336 pma/510(k) number not available.It is unknown at this time if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during placement of the implant while transferring to the patient's mouth, the implant fell onto the tray.The procedure was completed successfully using another implant.

Manufacturer Narrative

One (1) unknown driver was not returned for investigation.Device malfunction could not be verified for the unknown driver.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimvie.Dhr, sterilization, and complaint history review could not be performed, as the subject item/lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation was missing or confusing instructions for use, the implant was not transferred from sterile environment to patient in accordance with ifu or the driver was unable to retain implant.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.H3 other text : no item/lot# and no product was returned.

Event Description

No additional event information received at the time of this report.

• Type of Device: DENTAL PLACEMENT TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16405646
• MDR Text Key: 309964726
• Report Number: 0001038806-2023-00335
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/31/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT- SEE H10 NARRATIVE