MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX 3MM HEX-HOLE SQ CONN 17MM SST; HEX TOOL

Catalog Number HX3.0-S

Device Problems Separation Failure (2547); Separation Problem (4043)

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

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint number (b)(4).

Event Description

It was reported that doctor placed the implant with the contra-angle.She finished the placement with the tool hex having removed previously the mount but it was impossible to remove the tool hex from the implant.She forced it out and the tool hex came with the implant, and it was difficult to separate them even outside the mouth.Procedure not completed.

Event Description

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

Manufacturer Narrative

Zimvie received one (1) hx3.0-s, (tool hex 3mm hex-hole sq conn 17mm sst) for evaluation.Product evaluation was performed.The returned implant was identified as reported.The implant has signs of use.During a functional test with the returned tool the implant disengaged/release as intended.No malfunction.The tool matched prints where measured.Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported products are not available.Zimvie 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 (hx3.0-s) 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 devices related to the reported event.Review completed utilizing keywords: ¿dental : functional : does not disengage/release¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-002w1 rev 8, the most likely root cause determined from the investigation was over use or mishandling causing wear.Tool unable to disengage.Therefore, based on the available information, a device malfunction did not occur.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: TOOL HEX 3MM HEX-HOLE SQ CONN 17MM SST
• Type of Device: HEX TOOL
• 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: 16989973
• MDR Text Key: 315817482
• Report Number: 0002023141-2023-01420
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: HX3.0-S
• 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: 05/03/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic