MAUDE Adverse Event Report: BIOMET 3I; PLACEMENT TOOL

Device Problem Device Damaged by Another Device (2915)

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

Event Date 09/14/2022

Event Type  Injury  

Event Description

It was reported that the doctor placed an implant at tooth location #30 and was torquing in very dense bone and the implant was stripped.The inside of implant was no longer gripping and was now stripped internally.The doctor attempted to use a screw removal tool (srt) but ended up breaking the inside of the implant.The implant was extracted and replaced with new implant.  .

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Concomitant medical products: xifnt613, osseotite tapered certain implant 6 x 13mm, lot number: 2019090910.Pma/510(k) number not available.It is unknown at this time if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The unknown driver was not returned, therefore visual examination could not be conducted.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported events.Monthly post market trending review identified no actionable trends or corrective actions for the reported events or devices.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown driver) is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A definitive root cause could not be determined.However, based on the investigation, ifu and risk file review, the most likely causes determined from the investigation are tool experiences loads that exceed the intended design parameters causing tool damage.Tool requires replacement, torque applied during placement/seating exceeds recommended value, inadequate handling by clinician or staff.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

Event Description

No additional event information received at the time of this report.

• Type of Device: PLACEMENT TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15615869
• MDR Text Key: 301841647
• Report Number: 0001038806-2022-01567
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male