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

Catalog Number	UNISG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product and therapy dates: unisg, gold-tite® square uniscrew, lot number: 1246019.
Event or Problem Description
The doctor reports a fixed metal-ceramic bridge screwed with abutments on #44 and #46 and a pontic on #45.The doctor notes that both goldtite components broke in 2021 and broke again in 2023.The procedure was concluded by placing two additional screws without any impact on the patient.The doctor reported: bruxism; bone type: ii.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D1: brand name updated.D3: manufacturer email address.D4: additional device information.D6: implant date unknown.D9: device availability.G1: contact office (and manufacturing site for devices) contact name and email.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.H10: additional narrative.Zimvie received one (1) unisg, (gold-tite® square uniscrew) for evaluation.Visual evaluation of the as returned device identified the screw with signs of use.Screw fracture identified at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1246019.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 1246019 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture screw the customer did not submit images for the reported event.Ifu review: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev.H 2024/01.Information identified: potential adverse events based on the investigation and risk management file review as per rmf rm-00057-haz rev.20, the most likely root causes determined from the investigation are parafunctional habits/patient factors.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.H3 other text: investigation results.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: GOLD-TITE SQUARE 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18496411
• Report Number: 0001038806-2024-00049
• Device Sequence Number: 6985430
• Product Code: NHA
• UDI-Device Identifier: 00844868017325
• UDI-Public: (01)00844868017325(17)260714(10)1246019
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• 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): 06/21/2024

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: 07/14/2026
• Device Catalogue Number: UNISG
• Device Lot Number: 1246019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• 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: 01/11/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL SCREW; DENTAL SCREW
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic