MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER

Device Problem Device Damaged by Another Device (2915)

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

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event 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.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported that the implant was placed and removed during surgery.The implant may have been damaged during placement.

Manufacturer Narrative

One(1) imp,tsv,4.1,11.5,mtx,mg (b)(6) was returned for investigation.The unknown device was not returned.Visual evaluation of the as returned product identified damage to the collar and drive feature of the implant observed.Dimensions measured and match print.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing condition noted, and no per form was provided.Bone density type is unknown.The reported implant was located on an unknown tooth site (universal) and was used, placed and removed on the same day.The length of the unknown device usage is unknown.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1255445).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown device) is not available.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review was performed for the reported lot number (1255445) for similar events and one (1) other complaint was identified, (b)(4).(b)(6) post market trending was reviewed and there were no actionable events or corrective actions for the reported events (damaged drive feature & unable to place implant into osteotomy) or product ((b)(6), unknown device).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, implant malfunction did occur, and the reported event (damaged drive feature) was confirmed.The unknown device malfunction and the reported events (damaged drive feature & unable to placed implant into osteotomy) could not be verified with the information provided.

Event Description

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

• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15993031
• MDR Text Key: 305581231
• Report Number: 0002023141-2022-03143
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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: 12/15/2022
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/29/2023
• 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 Sex: Prefer Not To Disclose