MAUDE Adverse Event Report: BIOMET 3I UNKNOWN PLACEMENT DRIVER

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product device code unknown.Expiration date unknown.Device manufacture date: unknown.The device item and lot is unknown, the device was not returned for evaluation.A supplemental report will be submitted if additional information becomes available.

Event Description

It was reported by the distributor that the implant fell down to the floor during a procedure using an unknown placement driver to place the implant.Another implant was placed and there was not report of patient injury or harm.

Manufacturer Narrative

This report is being submitted to relay additional and corrected information.The following sections are being reported: d11:3i t3® with dcd® non-platform switched tapered implants 4 x 11.5mm item #: bnst411 lot #: 2017021528.It was reported by the distributor that the implant fell down to the floor during a procedure to place the implant at tooth location 46.Another implant was placed and there was not report of patient injury or harm.Age or date of birth: 35 years.Sex: female.Date rec¿d by mfr: 25 apr 2019.The reported device was not returned for evaluation as the customer reported that it was working properly.No investigation was completed on the reported unknown driver.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the distributor that the implant fell down to the floor during a procedure to place the implant.Another implant was placed and there was not report of patient injury or harm.

• Brand Name: UNKNOWN PLACEMENT DRIVER
• Type of Device: PLACEMENT DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8327791
• MDR Text Key: 136305137
• Report Number: 0001038806-2019-00095
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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 Model Number: N/A
• Device Catalogue Number: UKN IMPLANT PLACEMENT DRIVER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 35 YR