MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

Device Problem Separation Failure (2547)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number: (b)(4).Weight: unknown / not provided.Date of event: unknown / not provided.Brand name: unknown / not provided.Catalog and lot number: unknown / not provided.Dental implant: xiitp5485, osseotite tapered certain prevail implant 5/4 x 8.5mm, lot number: 2022011159.No device catalog or lot number was provided so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.

Event Description

It was reported that the internal connection locked the driver into the implant connection on tooth site #18.No patient impact was reported.A different implant was used to complete the procedure.

Event Description

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

Manufacturer Narrative

This report is being submitted to relay corrected data.Corrected data: the driver was not returned.It was reported as returned to manufacturer in error on the initial report: 0001038806-2022-01614.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D9: device availability was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The driver was not returned.The reported event was non-verifiable without return of the device involved.Based on the evaluation device malfunction could not be verified.Additionally, 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 event.Monthly post market trending review identified no actionable events or corrective actions for the reported event or devices.Zimvie 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 zimvie.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown biomet driver) is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A definitive root cause could not be determined.However, based on the investigation, ifu and risk files, the most likely cause determined from the investigation is failure to follow recommended guidance for usage in surgical manual -- torque or speed applied during placement/seating exceeds recommended value.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 was received at the time of this report.

• Type of Device: DENTAL DRIVER
• 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: 15658365
• MDR Text Key: 305348972
• Report Number: 0001038806-2022-01614
• 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,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE.
• Patient Age: 40 YR
• Patient Sex: Male