MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT; DENTAL TOOL

Catalog Number IIPDTUS

Device Problem Separation Failure (2547)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

It was reported that during implantation, the placement driver was squeezed into the implant at tooth location #5 and did not come out.The procedure was completed with a different driver and implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).D10: bopt4311, 3i t3 tapered implant 4/3 x 11.5mm/lot# 2022071121.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.

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.D9: device availability and return date were 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: type of investigation codes were added: 10, 4109 and 4111.H6: investigation findings code was added: 180.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported driver tool for evaluation.Visual evaluation / functional test was performed, the driver does not disengage from implant.Malfunction.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 iipdtus dating back to 12 months.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the clinician does not follow the recommended guidance for usage in surgical manual.Therefore, based on the available information, device malfunction did occur.The driver does not disengage from implant.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT
• 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 ; 5619713230
• MDR Report Key: 18659843
• MDR Text Key: 334769425
• Report Number: 0001038806-2024-00191
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2024

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 Catalogue Number: IIPDTUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic