MAUDE Adverse Event Report: BIOMET 3I CERTAIN 3.4MM(D) DRIVER TIP - SHORT; DENTAL DRIVER

Catalog Number IMPDTS

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that during a 2 implant placement surgery.While placing the second implant, this one could only be inserted partially.Despite trying to place it mechanically, and manually with a ratchet, the driver tip did not have a grip into the implant and it was finally removed.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One reported certain® 3.4mm(d) driver tip - short (impdts), one reported 3i t3® non-platform switched tapered implant 3.25 x 11.5mm (bost3211) were returned for investigation.Visual evaluation of the as returned products identified signs of use, rust and blood on the devices and a heavily contaminated implant drive feature on the implant.The impdts had damage around the drive feature.The returned implant matched print specifications where measured during the physical inspection on (b)(6) 2020 using a caliper (cal312, calibration due: (b)(6) 2021).Functional testing was performed for the returned products (impdts & bost3211) and it was determined the impdts would not engage with the returned implant as the implant kept falling down due to the observed damaged drive feature.The reported event was able to be recreated with the returned impdts and bost3211 as the driver tip did not have a grip in the implant during functional testing.No pre-existing conditions were noted by the customer on the per.The patient had moderate (type ii) bone density.The reported devices were used on tooth # 47 (fdi) and the implant was used for the during the placement procedure (1 day) while the driver was used for an unknown duration.The customer did not provide pictures or additional evidence.Device history record review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (impdts) 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 (impdts) 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 events.(complaint category keyword(s): 'device malfunction', 'damaged drive feature', 'does not assemble').July post market trending was reviewed and there were no actionable events or corrective actions for the reported events or devices.Therefore, based on the available information, device malfunction did occur for the reported impdts and the device malfunction related to the implant placement cannot be recreated.Additionally, the reported event (damaged drive feature) was confirmed.

Event Description

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

• Brand Name: CERTAIN 3.4MM(D) DRIVER TIP - SHORT
• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11640009
• MDR Text Key: 244615263
• Report Number: 0001038806-2021-00580
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IMPDTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR