MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER

Device Problem Mechanical Problem (1384)

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

Event Date 02/19/2023

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).A1: patient identifier is not provided / unknown.A4: patient weight is not provided / unknown.D1: brand name is not provided / unknown.D4: catalog number and lot number are not provided / unknown.D10: unknown encode abutment, lot number unknown and tsv6h10, impl tapered scr-v ha 6mm 5.7mm 10mm, lot number 1256652.E1: initial reporter¿s title is not provided / unknown.

Event Description

It was reported that the driver would not screw in encode in the implant and the implant had to be removed.Tooth 18.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report additional information.One unknown driver was not returned for evaluation.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the unknown driver is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.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.

Event Description

Follow up with the customer confirmed that they had some encode abutments at the office that they were trying to match with implants.The implant was only opened to determine if it fits the encode.The implant was never used on a patient or for a procedure.There is no issue with the encode, implant or driver.

Manufacturer Narrative

This report is being submitted to report corrected information to 0002023141-2023-03324-1.Further evaluation of this event confirms that this event no longer meets the requirement of a reportable event.There will be no further medwatch submitted for this event.

• Type of Device: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18184227
• MDR Text Key: 328695422
• Report Number: 0002023141-2023-03324
• 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,Followup
• Report Date: 11/27/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/27/2023; 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DENTAL ABUTMENT AND IMPLANT, SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic