MAUDE Adverse Event Report: ZIMMER DENTAL TWIST HA 3.25MMX13MM; DENTAL IMPLANT

Model Number	2133
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dr.Indicated malfunction.While placing the implant, the physician felt that the screw on the fixture mount was loose, so he removed that implant and reinserted another product.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Ne (1) twist ha 3.25mmx13mm (2133) was returned for investigation.Visual evaluation of the as returned product identified the screw with signs of use, wear.A fracture was identified at the platform connection.One of the fingers was missing.The remaining fingers were all damaged possibly from being over torqued.Additionally, the screw threads were damaged.When the screw is placed in the mount, it felt loose.Unable to connect mount to implant.However, due to the screw thread damage the screw could not be functionally tested.Thread damage was viewed inside the implant.Possibly from cross threading.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was low bone density (type iii).The reported device was located on tooth # 8 (universal) and was implanted and explanted on the same day.X-ray & picture evaluation: the customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2021050009.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 2021050009 for similar events and no other complaint was identified.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed as physical evaluation identified the implant had damaged internal threads and the screws threads were damaged which could not be verified.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: TWIST HA 3.25MMX13MM
• 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: 15461917
• Report Number: 0002023141-2022-02430
• Device Sequence Number: 14171414
• Product Code: DZE
• UDI-Device Identifier: 00889024013308
• UDI-Public: (01)00889024013308(17)260907(10)2021050009
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 09/07/2026
• Device Model Number: 2133
• Device Catalogue Number: 2133
• Device Lot Number: 2021050009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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 Age: 62 YR
• Patient Sex: Female