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

Catalog Number HX1.25

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that the patient swallowed the tool during a procedure, patient is okay, tool was found in his stomach.It is unknown if the tool was removed or not, patient feels well.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The tool hex sst 1.25mm 17mm (hx1.25) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.The reported event could not be recreated due to the nature of the dental device and event (ingested device).Device history record (dhr) 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 by item number was conducted for the hx1.25 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

Event Description

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

• Brand Name: TOOL HEX SST 1.25MM 17MM
• Type of Device: HEX TOOL
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11036021
• MDR Text Key: 222283332
• Report Number: 0002023141-2020-02340
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HX1.25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention