MAUDE Adverse Event Report: ZIMMER DENTAL 30 DEG TAPER 4.5P 4MM-6MM; DENTAL IMPLANT

Model Number	30AT446
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the abutment was loose, which caused the screw to deform and could not be locked with additional force, resulting in failure, so the implant at tooth location #35 was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier - (b)(6).Weight unknown / not provided.Concomitant medical products: tsv4b11, imp, tsv, 4.1mm, sbm, 11.5/ lot number: 63850943.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information 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: h6: investigation type codes were added: 3331, 4109 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 4315.One (1) 30 deg taper 4.5p 4mm-6mm (30at446) was returned for investigation.Visual evaluation of the returned product identified signs of use.Functional testing to recreate the reported event identified that screw was identified as damaged as it was not firmly attached to the abutment.Based on the evaluation, device malfunction (loosening) could not be verified.However, during functional testing the screw was damaged.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Zimvie 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 conforming when it left zimvie.Dhr review was completed for the subject lot number 63792197.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 63792197 for similar events and other 3 relevant complaint(s) were identified.Functional testing to recreate the reported event identified that screw was identified as damaged as it was not firmly attached to the abutment.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation was missing or confusing instructions for use, the abutment screw was not torqued to specification, product was placed incorrectly, the driver feature is oversized (too wide) and/or undersized (reduced height), the clinician damages the screw surface or patient factors.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: 30 DEG TAPER 4.5P 4MM-6MM
• Common Device Name: DENTAL IMPLANT
• 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: 16263691
• Report Number: 0002023141-2023-00363
• Device Sequence Number: 6066987
• Product Code: DZE
• UDI-Device Identifier: 00889024013612
• UDI-Public: (01)00889024013612(17)220930(10)63792197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111853
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 30AT446
• Device Catalogue Number: 30AT446
• Device Lot Number: 63792197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male