MAUDE Adverse Event Report: ZIMMER DENTAL 1.25MM HEX TL,LONG GEMLOC; HEX DRIVER

Catalog Number HXLGR1.25

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device will not be returned to zb.

Event Description

It was reported that the patient swallowed the wrench while placing healing collars in the patient's mouth.No medical intervention required, patient was able to pass the device from her gi tract days later without any complications.

Manufacturer Narrative

Product evaluation: one 1.25mm hex tl,long gemloc (hxlgr1.25) was not returned for investigation as it was ingested.Since the product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available device information.Pre-existing patient conditions are not related to the reported event.However, it was noted on the per that the patient had unknown bone density and they were operating on tooth 29/30.The tool was used for an unknown duration and was reported during use.The customer did not provide pictures or evidence of the ingestion.It was reported the event happened on (b)(6) and on (b)(6)x-rays showed the device was passed by the patient.Dhr review and complaint history 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 (hxlgr1.25) 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 device related to the reported event.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event/failure or device.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable as there was no objective evidence provided for the ingestion event.Sections updated: b4: date of this report.G3: date pce/investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated based on the item number provided.H6: adverse event problem codes.H10: manufacturer's narrative.

Event Description

There is no update to the original complaint description provided.

• Brand Name: 1.25MM HEX TL,LONG GEMLOC
• Type of Device: HEX DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10938240
• MDR Text Key: 219310736
• Report Number: 0002023141-2020-02139
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HXLGR1.25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR