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

Catalog Number IIPDTUL

Device Problem Separation Problem (4043)

Patient Problem No Code Available (3191)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Lot number, expiration date and udi unknown / not provided.

Event Description

It was reported that during implant placement applying a 25n torque, when removing the driver the implant was also removed.When placing the implant doctor was not able to remove the mount and the implant came out.Doctor placed another implant of lager diameter at the same surgery.

Manufacturer Narrative

One internal connection universal placement driver tip - long (iipdtul) was not returned to palm beach gardens for investigation.Since the reported product has not been returned for investigation, visual/functional evaluation could not be performed.The investigation has been performed based on the available device information.No pre-existing conditions were noted on the per.The patient had moderate (type ii) bone density.The reported device was used on tooth # 15 (fdi) and the implant was used for a single day/procedure while the iipdtul was used for an unknown duration.Pictures were not provided.Iipdtul review of appropriate documentation: documents reviewed: instructions for use for biomet 3i kits and instruments (p-zbdinstrp) rev.C - nov 2019 information identified: warnings and precaution recommended procedures for cleaning and sterilization of surgical instruments and kits dhr review and complaint history review could not be performed, as the lot number associated with the reported product (iipdtul) is not available.Zimmer biomet 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 (iipdtul) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.April post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (iipdtul).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable for the reported device.Zimmerbiomet complaint number (b)(4).The following sections have been updated: 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: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9943450
• MDR Text Key: 187195105
• Report Number: 0001038806-2020-00653
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/18/2020

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: IIPDTUL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR