MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX SST 1.25MM 17MM; DENTAL DRIVER

Catalog Number HX1.25

Device Problem Fracture (1260)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that tool fractured.Discomfort was reported as a result of the event.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

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

Manufacturer Narrative

Zimvie complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.' h3: device evaluated by manufacturer: change ¿no' to 'yes.' one tool and one healing abutment were returned for investigation.Visual evaluation of the as returned products identified the returned tool exhibited signs of wear and was fractured in the hex region.The healing collar (hc) exhibited signs of wear and had a damaged hex.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition was not noted on the per form.Bone density was unknown.The reported device was located at an unknown tooth location.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: instructions for use for zimmer® instrument kit system and driva¿ drills - 8874 rev 6 - 10/22.Information identified: warnings, precautions, sterilization.Dhr review: (hx1.25).Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.Complaint history review: a complaint history review by item number was conducted for the (hx1.25) dating back to 12 months prior to the notification date.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 event.Review completed utilizing keywords: 'dental : functional : fracture and dental : functional : damaged drive feature.' post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: TOOL HEX SST 1.25MM 17MM
• 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: 16399559
• MDR Text Key: 309897557
• Report Number: 0002023141-2023-00589
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HX1.25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1