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

Catalog Number IIPDTUL

Device Problem Fracture (1260)

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

Event Type  Injury  

Event Description

It was reported that the customer has 2 implant placement drivers spinning in the implant.Customer reported that they were able to complete the procedure with another driver.However, during product evaluation an unknown biomet implant was returned with a piece of a fractured driver stuck inside.The drivers (iipdtus & iipdtul) were not returned.Additionally, it is unknown which driver fractured within the implant.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01912.Zimmer biomet complaint number (b)(4).The drivers were not returned for investigation, so visual evaluation could not be performed.One unknown biomet implant was returned for investigation.Visual evaluation of the unknown biomet implant identified signs of use and a fractured piece from an unknown driver was seen stuck inside the implant.Functional testing to recreate the reported event could not be performed due to the nature of the devices & event.Based on the evaluation, device malfunction and the reported event could not be verified as the drivers were not returned and we are unable to verify what caused the driver to fracture within the unknown biomet implant.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or 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 devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore; based on the available information, the products were within specifications and conforming when they left zimvie.Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported products are not available.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (iipdtus & iipdtul) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported devices related to the reported event.The complaint is related to the functional performance of the devices.Functional testing to recreate the reported event could not be performed due to the nature of the devices & event.A definitive root cause could not be determined.However, based on the investigation, ifu and risk file review, the most likely cause determined from the investigation is clinician does not follow recommended guidance for usage in surgical manual.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.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• 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: 15990789
• MDR Text Key: 305584139
• Report Number: 0001038806-2022-01916
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• 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
• Patient Outcome(s): Required Intervention