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

Model Number	RHD2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the implant became detached from the driver.The doctor confirms that the dental surgical procedure was completed with another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) imp,tsv,4.1mm,dual sel,ha (tsv4h8) was returned for investigation.Visual evaluation of the as returned product identified the implant and mount attached with minor signs of use.A stock rhd2.5 was used to attach to the implant without a problem.The rhd2.5 listed in the complaint was not returned.Device history record (dhr) review was completed for the subject lot numbers (2020031404, 63582791).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2020031404, 63582791) for similar events and no other complaint was identified.Review completed utilizing keywords: disengaged.Based on the available information, implant malfunction did not occur and the reported event was non-verifiable without return of all items involved.Therefore, driver malfunction could not be verified.H3 other text : product not returned.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: RETAINING 2.5MM HEX DRIVE R LATCHLOCK
• Common Device Name: 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 ; 5617766700
• MDR Report Key: 14883832
• Report Number: 0002023141-2022-01688
• Device Sequence Number: 5062593
• Product Code: NDP
• UDI-Device Identifier: 00889024016705
• UDI-Public: (01)00889024016705(17)991231(10)2020031404
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: RHD2.5
• Device Catalogue Number: RHD2.5
• Device Lot Number: 2020031404
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male