MAUDE Adverse Event Report: BIOMET 3I; DENTAL INSTRUMENT

Catalog Number UNKNOWN HANDPIECE CONNECTOR

Device Problem Premature Separation (4045)

Patient Problem No Information (3190)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Device manufacturer date unknown.

Event Description

It was reported that the implant fell down during placement.After a follow up, doctor confirmed that the implant disengaged from handpiece connector.The procedure was completed using another implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Product evaluation: one osseotite® tapered implant 5 x 8.5mm (nt585) and mount were returned for investigation.However, an unknown handpiece connector was not returned.Therefore, visual evaluation of the handpiece connector could not be performed.Visual evaluation of the as returned implant identified that the device was in good condition.Pre-existing patient conditions, tooth location and x-ray images are irrelevant to this investigation.Doctor was attempting to place the implant when the incident occurred.Pictures were not provided and no other information was provided.Dhr and complaint history reviews could not be performed as the lot and item numbers associated with the reported device were not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.February post market trending was reviewed and there were no negative trends or corrective actions for the reported event or devices.Therefore, based on functional testing, the reported malfunction (implant-related) did not occur.However, since the unknown handpiece connector was not returned, malfunction could not be verified.Additionally, the reported event could not be verified.

Event Description

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

• Type of Device: DENTAL INSTRUMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9685827
• MDR Text Key: 182702598
• Report Number: 0001038806-2020-00304
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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: UNKNOWN HANDPIECE CONNECTOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1