MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 8 MM; DENTAL IMPLANT

Model Number	1988
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number ¿ k943604.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The doctor noticed that the fixture mount was loose before the implant was placed.However, when the implant was placed in that condition, the slot part of the fixture mount and the tine part of the implant body ruptured.The doctor stopped using the implant and placed another implant.
Event or Problem Description
No additional event information 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.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.H6: tyoe of investigation code was added: 3331, 4109, 4110 and 4111 h6: investigation findings code was added: 213 h6: investigation conclusions codes were added: 4310 h10: narrative/data was updated.One impl twist mp-1 3.75 mm 8 mm (1988), mount and mount screw were returned for investigation.Visual evaluation of the as returned products identified debris around the screw threads and damage around the implant splines/platform possibly due to the removal/placement - damage observed on returned implants due to trephine removal is not considered a malfunction or failure of the device.Zimmer biomet is not responsible for any damage caused by the clinician's removal of the device.No rupture/fracture was identified with any of the devices.They were returned outside of the original packaging ¿ packaging was already opened.Therefore, the complaint could not be verified.The products were returned outside of the original packaging without evidence of malfunction that correlates with the complaint description.The complaint out of box (coob) failure could not be confirmed since the condition of the products as received by the customer was nonverifiable.Based on the evaluation, device malfunction has not occurred - the products were damaged during removal/placement which is not considered a device malfunction.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices/packaging that did or could cause or contribute to the reported events.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.However, based on the available information, the condition of the products as received by the customer could not be determined.Dhr review for the lot (2020060164) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.The dhr was further reviewed to verify the packaging process.No malfunction or nonconformance was identified.Complaint history review was performed for the reported lot number (2020060164) for similar events (complaint category keyword: fracture) and no other complaint was identified.Functional testing to recreate the reported event could not be performed due to the nature of the devices and events.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.Based on the investigation and risk file review, the most likely cause to the reported event is mishandling of product outside of zimmer biomet controls - product not placed properly.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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 3.75 MM 8 MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12549915
• Report Number: 0002023141-2021-02717
• Device Sequence Number: 972934
• Product Code: DZE
• UDI-Device Identifier: 00889024013117
• UDI-Public: (01)00889024013117(17)250610(10)2020060164
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 06/10/2025
• Device Model Number: 1988
• Device Catalogue Number: 1988
• Device Lot Number: 2020060164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1