MAUDE Adverse Event Report: BIOMET 3I TITANIUM HEXED UNISCREW; DENTAL SCREW

Model Number	UNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that screw fractured at the thread of the screw.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Weight unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional report submitted to updated udi number that has not been included in the previous reports.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d4: expiration date d4: udi unknown g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' *h4: device manufacture date h6: evaluation codes h10: additional narrative one screw was returned for investigation.Visual inspection via naked eye and camera magnification confirmed that the screw was fractured at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing conditions noted on the complaint: bruxism; patient has night-guard.The reported device was located on unknown tooth site.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 (1210940).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 conducted for the subject lot number (1210940) and revealed that there are no existing nonconformances/capa/hhe/d/ie/product holds for the reported device related to the reported event for similar events (complaint category keywords: fracture screw).Post market trend review: july post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device (uniht).Based on the available information, device malfunction did occur and the reported event was confirmed following inspection and evaluation.

• Brand Name: TITANIUM 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: 14098941
• Report Number: 0001038806-2022-00517
• Device Sequence Number: 4676727
• Product Code: NHA
• UDI-Device Identifier: 00844868017318
• UDI-Public: (01)00844868017318(17)221019(10)1210940
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 10/19/2022
• Device Model Number: UNIHT
• Device Catalogue Number: UNIHT
• Device Lot Number: 1210940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 09/27/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 09/14/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2017
• 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: Unknown