MAUDE Adverse Event Report: ZIMMER DENTAL ABUT BALL SWISSPLUS OCTAG ON IMP 1.6MM; DENTAL SCREW

Catalog Number	OPBA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that looseness seems to occur with this abutment screw about three (3) days before it fractures.Tooth site #5.This event captures screw loosening.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown/not provided.D10: spb10, impl tapered sp 3.7mm 10m m octagon/lot# unknown.The device will not 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
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: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 1260.H6: investigation conclusions code was added: 4307.Zimvie received the reported abutment for evaluation.Visual evaluation was performed, signs of usage and fracture at the threads.Dhr review was completed for the subject lot number 2020091270.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 2020091270 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 not torqued to specification.Therefore, based on the available information, device malfunction for the reported event (loosening) could not be verified.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: ABUT BALL SWISSPLUS OCTAG ON IMP 1.6MM
• Common Device Name: DENTAL SCREW
• 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 ; 5619713230
• MDR Report Key: 17763735
• Report Number: 0002023141-2023-02555
• Device Sequence Number: 6995664
• Product Code: DZE
• UDI-Device Identifier: 00889024015838
• UDI-Public: (01)00889024015838(17)250925(10)2020091270
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002188
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 03/07/2024

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: Lay User/Patient
• Device Expiration Date: 09/24/2025
• Device Catalogue Number: OPBA
• Device Lot Number: 2020091270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic