MAUDE Adverse Event Report: ZIMMER DENTAL XFR HEX DIRECT SCR-V 4.5M M NECK 4.5MM IMP; DENTAL SCREW

Model Number DHT4/4

Device Problem Unintended Movement (3026)

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

Event Date 07/18/2022

Event Type  Injury  

Event Description

It was reported that the screw became loosened on tooth site #19 prior to the neck of implant being fractured.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0002023141-2022-01918.Zimmerbiomet complaint number (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0002023141-2022-01918-2.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were updated: 3331, 4109, 4110, 4111.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.One xfr hex direct scr-v 4.5m m neck 4.5mm imp (dht4/4) was returned for investigation.The reported loosening event could not be verified.Based on the evaluation, device malfunction could not be verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the lots (2020091375) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number (2020091375) for similar events and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event.The complaint is related to the functional performance of the device.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation is clinician¿s error while removing implant.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

Event Description

No additional event information was received at the time of this report.

• Brand Name: XFR HEX DIRECT SCR-V 4.5M M NECK 4.5MM IMP
• Type of Device: DENTAL SCREW
• 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: 15983020
• MDR Text Key: 306982079
• Report Number: 0002023141-2022-03100
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00889024014602
• UDI-Public: (01)00889024014602(17)251001(10)2020091375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DHT4/4
• Device Catalogue Number: DHT4/4
• Device Lot Number: 2020091375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG