MAUDE Adverse Event Report:; DENTAL INSTRUMENT

Device Problem Mechanical Problem (1384)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Udi not available.Pma/510(k) number not available.

Event Description

It was reported that during placement procedure the implant was stripped out as it was impossible to use the instrument to torque the implant.Implant was removed and another one was placed.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One imp,tsv,6.0,10,mtx,mg (tsvt6b10) was returned for investigation.The reported unknown lz instrument was not identified or returned.Visual inspection of the as returned product identified minimal signs of wear from use and about the implant drive feature.The device functioned as intended when fully assembled with the returned mount and mount screw.No pre-existing conditions were noted on the per.The reported implant was located on an unknown tooth site and was removed the same day as placement.Device history recrod review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.July post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (tsvt6b10 + zimmer placement instruments).Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable without return of all components reported.

• Type of Device: DENTAL INSTRUMENT
• MDR Report Key: 11783280
• MDR Text Key: 251794537
• Report Number: 0002023141-2021-01152
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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