MAUDE Adverse Event Report: BIOMET 3I NARROW STANDARD LARGE HEXED DRIVER, 24MM; DENTAL DRIVER

Catalog Number PHD03N

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).E1: phone number: (b)(6).

Event Description

It was reported, that the driver fractured at the tip.Tooth site 24, procedure not completed.

Manufacturer Narrative

Zimvie received one (1) phd03n, (narrow standard large hexed driver, 24mm) for evaluation.Visual evaluation of the as returned device identified the driver with signs of use, wear and was attached to what appears to be dental floss.The driver was observed fractured at the tip, and was worn out from use.The returned driver was identified as reported.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the phd03n dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: ¿fracture" & "wear¿.The customer did not submit images for the reported event.Ifu review: documents reviewed: instructions for use for biomet 3i kits and instruments (p-zbdinstrp) rev.F 2023/12/01.Information identified: "warnings" "contraindications" "precautions" based on the investigation and risk management file review as per rmf rm-00291-haz rev.3, the most likely root causes determined from the investigation are customer error, incorrect techniques used.Therefore, based on the available information, a device malfunction did occur.The reported events were confirmed with all the available information.No further investigation or 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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

Event Description

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

• Brand Name: NARROW STANDARD LARGE HEXED DRIVER, 24MM
• Type of Device: DENTAL DRIVER
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18655494
• MDR Text Key: 334722442
• Report Number: 0001038806-2024-00186
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PHD03N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic