MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 5.0 MM 8 MM; DENTAL IMPLANT

Catalog Number	1993
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that the implant was removed due to requests for investigation.Upon investigation, a malfunction was identified.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).G4: additional pma/510(k) number ¿ k011028 | k013227.Zimvie received the reported implant for evaluation.Visual evaluation / functional test was performed, implant shows slight wear and mount cannot be disengaged.Malfunction.Dhr review was completed for the subject lot number 2021010261.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2021010261 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque or speed applied during placement/seating exceeds recommended value.Therefore, based on the available information, device malfunction did occur.The mount was not able to disengage from implant.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 5.0 MM 8 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18959190
• Report Number: 0002023141-2024-00905
• Device Sequence Number: 9446166
• Product Code: DZE
• UDI-Device Identifier: 00889024013162
• UDI-Public: (01)00889024013162(17)260511(10)2021010261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013494
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: Other
• Device Expiration Date: 05/10/2026
• Device Catalogue Number: 1993
• Device Lot Number: 2021010261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic