MAUDE Adverse Event Report: ZIMMER DENTAL CERTAIN TITANIUM LARGE HEXED SCREW; DENTAL SCREW

Catalog Number	ILRGHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).B3: date of event unknown / not provided e1: reporter name unknown / not provided g4: premarket identification k072642.
Event or Problem Description
It was reported that the screw fractured and had to be removed.During removel, screw removal tool was fractured.Procedure was completed placing a new screw.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.It was reported that the screw fractured and had to be removed.During removal, screw removal tool was fractured.Procedure was completed placing a new screw.Zimvie received one (1) ilrght, (certain¿ titanium large hexed screw) for evaluation.Visual evaluation was performed, the screw was fractured at the threads.Dhr review was completed for the subject lot number 1256708.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 1256708 for similar events and 2 other relevant complaint(s) were identified.Review completed utilizing keywords: dental: functional: fracture: screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was material selection of the product is not adequate to withstand occlusal forces.Therefore, based on the available information, a device malfunction did occur.The screw was fractured inside an implant.The reported event was confirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: CERTAIN TITANIUM LARGE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens AR 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL ; AL
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18501688
• Report Number: 0002023141-2024-00061
• Device Sequence Number: 7950824
• Product Code: DZE
• UDI-Device Identifier: 00844868006138
• UDI-Public: (01)00844868006138(17)270719(10)1256708
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K972444
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 Catalogue Number: ILRGHT
• Device Lot Number: 1256708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic