MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 11 .5 MM; DENTAL IMPLANT

Model Number	2121
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).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 when the physician attempted to place the implant at tooth site #30, the screw to connect it to the fixture mount broke off.The physician removed the implant and used a different product.
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) impl twist mp-1 5.0 mm 11.5 mm (2121) was returned for investigation and was reported as fractured screw.Visual evaluation of the as returned product identified signs of use.The returned screw was not fractured but did exhibit wear at the first couple of threads.Additionally, the implant¿s internal drive feature had damage near the top of implant which was then investigated as damaged drive feature.The reported event was unconfirmed; however, during inspection it was noted that the implant¿s drive feature was damaged, and the event of damaged drive feature was confirmed.Based on the evaluation, the device malfunction did occur.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 for the lot (2021050611) revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.The complaint is related to the functional performance of the device.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Therefore, the reported events could not be recreated.However, the investigated event of damaged drive feature was confirmed upon functional testing as the mount screw was unable to screw into the implant.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 clinician uses device improperly, insufficient instructions for use, insufficient training, and applied loads exceeding the normal functional design tolerances of the implant components.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: IMPL TWIST MP-1 5.0 MM 11 .5 MM
• 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: 15710343
• Report Number: 0002023141-2022-02748
• Device Sequence Number: 6630712
• Product Code: DZE
• UDI-Device Identifier: 00889024013278
• UDI-Public: (01)00889024013278(17)260722(10)2021050611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 07/22/2026
• Device Model Number: 2121
• Device Catalogue Number: 2121
• Device Lot Number: 2021050611
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 45 KG