MAUDE Adverse Event Report: ZIMMER DENTAL TWIST HA 3.25MMX10MM; DENTAL IMPLANT

Model Number	2130
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Age and date of birth: unknown / not provided.Patient sex: unknown / not provided.Patient weight: unknown / not provided.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
It was reported that the implant body at tooth site #7 cannot be removed from the fixture mount.The implant was removed, and another implant was placed.
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, 4110 and 4111.H6: investigation findings code was added: 180.H6: investigation conclusions codes were added: 4307.One (1) twist ha 3.25mmx10mm (2130) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Based on the evaluation, device malfunction did occur.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported product that did or 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.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 likely conforming when it left zimvie.Dhr review was completed for the subject lot number (2020120704).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 (2020120704) for similar events and no other complaint was identified.Functional testing to recreate the reported event; verified the implant and mount could not disengage.A definitive root cause could not be identified.However, based on the investigation, ifu and risk file review, the most likely causes determined from the investigation are clinician error, implant not placed properly, excessive insertion torque.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: TWIST HA 3.25MMX10MM
• 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: 16125300
• Report Number: 0002023141-2023-00099
• Device Sequence Number: 20428771
• Product Code: DZE
• UDI-Device Identifier: 00889024013285
• UDI-Public: (01)00889024013285(17)251212(10)2020120704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: Health Professional
• Device Expiration Date: 12/12/2025
• Device Model Number: 2130
• Device Catalogue Number: 2130
• Device Lot Number: 2020120704
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown