MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE® HEXED UNISCREW; DENTAL SCREW

Model Number	UNIHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the screw fractured at the body.The doctor confirms that the procedure was completed with another screw and that the patient did not suffer any negative impact on his health as a result of the event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).One screw was returned for investigation.Visual inspection via naked eye and camera magnification identified the screw was fractured at the thread area into 3 parts.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Per: no pre-existing conditions were noted on the complaint record.Bone density type is unknown.Device was located on tooth site 36 (fdi) when the event occurred.Picture/x-rays: pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: 'precautions' 'breakage' 'warning' per the applicable ifu, breakage may occur when device is loaded beyond its functional capability.Dhr review: dhr review was completed for the subject lot number (1247250).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: a lot specific complaint history review was performed for the subject lot number (1247250) for similar events (complaint category keywords: fracture screw) and revealed there are no existing non- conformances / capa / hhe / d / ie / product holds for the reported product.Post market trend review: october post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture) and device (iunihg).Malf/event: based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: GOLD-TITE® HEXED UNISCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15073407
• Report Number: 0001038806-2022-01090
• Device Sequence Number: 5501137
• Product Code: NHA
• UDI-Device Identifier: 00844868017301
• UDI-Public: (01)00844868017301(17)260830(10)1247250
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: Lay User/Patient
• Device Expiration Date: 08/30/2026
• Device Model Number: UNIHG
• Device Catalogue Number: UNIHG
• Device Lot Number: 1247250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 12/11/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 48 KG