MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT

Catalog Number IIPDTUS

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

Doctor reported that when she was trying to place the implant in tooth location #30 she used the short driver tip and it stripped out and the implant connection was damaged.The long driver was then used and it was not possible to removed the implant, it was half implanted and the drivers did not worked with the torque.Doctor finally removed the implant and place another implant with other driver tip.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative one osseotite® tapered certain® implant 4 x 11.5mm (xifnt411), one internal connection universal placement driver tip - short (iipdtus), and one internal connection universal placement driver tip - long (iipdtul) were returned for investigation.Visual inspection of the as returned product identified that implant has damage around the external threads and the collar.The drive feature is stripped and deformed.The drivers had no visible damage and functioned as normal with the in-house implant.No pre-existing conditions were noted on the per.The reported implant was located on tooth # 46 (fdi) and removed the same day as placement.Device history record (dhr) review could not be performed, as the lot numbers associated with the reported product are 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 iipdtus & 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 product.Therefore, based on the available information, device malfunction has occurred and the reported event, as it relates to the returned implant, was confirmed.The event as it relates to the returned drivers was unconfirmed following functional testing.

Event Description

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

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT
• Type of Device: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11040598
• MDR Text Key: 223183344
• Report Number: 0001038806-2020-02094
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR