MAUDE Adverse Event Report: ZIMMER DENTAL RETAINING 2.5MM HEX DRIVE R LONG; DENTAL IMPLANT DRIVER

Catalog Number RHL2.5

Device Problem Separation Failure (2547)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint(b)(4).

Event Description

During investigation, the driver was identified.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report additional information.Multiple reports are being submitted for this event.The following sections are being reported: h2: if follow-up, what type.H3: device evaluated by manufacturer.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received one driver for evaluation.Visual evaluation / functional test was performed, a driver was stuck inside the implant.Dhr review could not be performed since the lot number associated to the item was not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted 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 for similar events.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was excessive torque placed on tool due to improper surgical procedure or poor case planning.Tool connection is damaged and does not assemble with component.Therefore, based on the available information, a device malfunction did occur.A driver was stuck inside the implant.The reported event was confirmed.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.

• Brand Name: RETAINING 2.5MM HEX DRIVE R LONG
• Type of Device: DENTAL IMPLANT DRIVER
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18790048
• MDR Text Key: 336351619
• Report Number: 0002023141-2024-00508
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RHL2.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2024
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic