MAUDE Adverse Event Report: ZIMMER DENTAL TEMPORARY TI TAPERED ABUT; ABUTMENT

Model Number	ACTT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight not provided.Event date not provided.
Event or Problem Description
It was reported that the abutment screw loosened at the site.The patient reflected that he felt unwell when eating and did not know if it was caused by the screw loss.The restoration was removed.Pain was also reported.
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D4: udi number was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H4: device manufacturer date was updated.H6: type of investigation codes were updated: 3331, 4110, 4111, 4114.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.One (1) temporary ti tapered abut (actt) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr).Based on the evaluation, the device malfunction could not be verified.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (63631618).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 was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63631618) for similar events and no other complaint was identified.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.The complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely causes determined from the investigation are abutment breaks, not torqued to specification.No further investigation and no 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: TEMPORARY TI TAPERED ABUT
• Common Device Name: ABUTMENT
• 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: 15113514
• Report Number: 0002023141-2022-01884
• Device Sequence Number: 17642910
• Product Code: DZE
• UDI-Device Identifier: 00889024013704
• UDI-Public: (01)00889024013704(10)63631618
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: Lay User/Patient
• Device Model Number: ACTT
• Device Catalogue Number: ACTT
• Device Lot Number: 63631618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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: 55 YR
• Patient Sex: Male