MAUDE Adverse Event Report: BIOMET 3I; DENTAL TOOL

Device Problem Mechanical Problem (1384)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Brand name unknown / not provided.Dental implant: tsvt4b13, imp,tsv,4.1,13,mtx,mg, lot# 1253750.Catalog and lot number unknown / not provided.Pma/510(k) number not available.The device will not 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 a patient presented for placement of an implant at tooth location #9.The doctor did not have the surgical kit needed and borrowed a kit from their sales representative.It was noted that the kit was incomplete and some of the drills were unusable.As such, the drilling protocol had to be somewhat modified.Upon placement, the driver was found to be broken and ultimately after trying to negotiate the implant placement, the implant was a spinner.With too little torque to place, the implant was removed, and the patient was rescheduled for another day.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 4110, 4111 and 4114.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 4315.H10: narrative/data was updated.One (1) unknown zimmer kit (furnished with an unknown driver) was not returned.Device malfunction could not be verified for the unknown driver from the unknown zimmer kit.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.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it 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.Functional testing could not be performed since the product was not returned.Therefore, the reported event couldn't be recreated.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 or poor tool designs leads to insufficient mechanical strength.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.

Event Description

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

• Type of Device: DENTAL 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: 16438005
• MDR Text Key: 310350016
• Report Number: 0001038806-2023-00364
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT:
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG