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

Catalog Number IIPDTUL

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that when torqueing, the implant driver got stuck in the implant.The implant was removed.Another implant and tool from the customer's inventory was used to complete the procedure.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified signs of use.No malfunction was noticed during product evaluation that will contribute to the event.Functional testing with an in-house component to recreate the reported event verified the driver easily disengaged/release.No pre-existing conditions were noted on the product experience report (per).Complainant reported that when torquing, the implant driver got stuck in the implant.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.A device history record (dhr) review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet 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 device dating back to 12 months.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.

Event Description

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

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Type of Device: IMPLANT 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13903386
• MDR Text Key: 287931743
• Report Number: 0001038806-2022-00435
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNK LB IMPLANT