MAUDE Adverse Event Report: ZIMMER DENTAL INDIRECT TRANSFER, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 3MM CUFF; DENTAL PLACEMENT TOOL

Model Number	CITNP33
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Concomitant medical devices: unk zimmer eztetic body 3.1 restorative 2.9, lot# unknown.Fax number unknown / not provided.At this time, it is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the impression coping did not release/disengage from the implant and was cut off.The implant is not compromised at this time.
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, 4111 and 4114.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67 and 4315.One indirect transfer, 2.9mmd platform, 3.7mmd emergence profile, 3mm cuff (citnp33) and unk zimmer eztetic body 3.1 restorative 2.9 were not returned for investigation.Visual evaluation could not be performed.The investigation was performed using applicable instructions for use, risk files and other available information.Based on the evaluation, device malfunction could not be verified.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices 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 devices.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the products were within specifications and conforming when they left zimmer biomet.Dhr review for the lot (2021041276) revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number (2021041276) for similar events (complaint category keywords: does not disengage/release) and no other complaint was identified.Functional testing could not be performed due to the nature of the devices and event.Therefore, the reported event could not be recreated.A definitive root cause could not be identified.However, based on the investigation and risk review, the probable causes for the reported events are improper techniques used during placement - incorrect assembly of devices or application of excessive torque.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.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: INDIRECT TRANSFER, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 3MM CUFF
• Common Device Name: DENTAL PLACEMENT TOOL
• 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: 12681760
• Report Number: 0002023141-2021-02978
• Device Sequence Number: 6231161
• Product Code: NDP
• UDI-Device Identifier: 00889024343528
• UDI-Public: (01)00889024343528(17)260504(10)2021041276
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 05/04/2026
• Device Model Number: CITNP33
• Device Catalogue Number: CITNP33
• Device Lot Number: 2021041276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE; DENTAL IMPLANT
• Patient Sex: Male