MAUDE Adverse Event Report: BIOMET 3I; DENTAL LOCATOR

Device Problem Fracture (1260)

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

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Brand name unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Last name unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported screw broken inside locator.Tooth number 4.

Event Description

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

Manufacturer Narrative

One 3i t3 tapered implant 4/3 x 13mm (bopt4313) and an unknown locator (manufactured by: zest anchors inc - supplier id: (b)(4) were reported for investigation.Bopt4313 was not returned.Visual evaluation of returned products identified a third-party implant with fragment of an unknown device inside.Three unsuccessful attempts were made to clarify the event and items involved.Since no information is known about compatibility of the third-party implant and the locator, the fragment could not be identified/confirmed as locator¿s.However, in order to complete this investigation, it is assumed that the third-party implant has been mistaken for bopt4313 and the locator fractured inside that device.The investigation focuses only on the zimvie implant and the related/reported event.Functional testing could not be performed due to the nature of the devices and event.Pre-existing condition noted on the per was diabetes.The devices were intended for tooth #4.X-ray & picture evaluation: no x-ray/picture provided.Appropriate documentation was reviewed.Dhr review for the lot (2018021156) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot (2018021156) and no other event or complaint was found.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction could not be verified for bopt4313.However, the reported event (locator screw fracture) was confirmed.

Event Description

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

Manufacturer Narrative

The zest quality assurance department has conducted an investigation into the product experience reported by you which included the below elements, as indicated: lhr review: no results are available since no zest lot number was provided by the customer.Data review: a review of other zest product experience files and related trending data for similar incidents was performed to evaluate whether other similar product experiences reports have been received and if data suggests any adverse trends may have contributed to the product experience root cause.Returned product evaluation: no product was returned (npr) to zest.Root-cause or most likely root-cause cannot be determined based upon the information provided.The reported product experience condition cannot be verified.No product was returned, and physical evaluation cannot be performed; therefore, no findings are available.Zest was unable to find evidence of a manufacturing issue per current records and believes that the components do not present any manufacturer errors.The issue is being tracked and trended with no further actions taken at this time.

• Type of Device: DENTAL LOCATOR
• 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: 16000351
• MDR Text Key: 305680136
• Report Number: 0001038806-2022-01920
• Device Sequence Number: 1
• Product Code: NHA
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 04/07/2023; 05/30/2023
• Supplement Dates FDA Received: 04/13/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female