MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW; DENTAL SREW

Model Number	ILRGHG
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
Zimmer biomet complaint number: (b)(4).Patient weight unknown / not provided.Date of event unknown / not provided.Pma/510k #: k072642.
Event or Problem Description
It was reported that screw broke in tooth site (part of a bridge).Tooth location: 12.Broken screw is still in the patient's mouth and will be removed in the next few days.Implant remains implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Two certain® goldtite® large hexed screw, ilrghg were not returned for investigation.Therefore, visual inspection could not be performed.The unknown zimmer implant remains implanted and therefore, could not be visually inspected.This investigation will be of the available information of the ifus and risk management files.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted and no per form was provided.Bone density type is unknown.The reported device were located on an tooth sites #11 & 13 and was used for an unknown amount of time.Picture/x-rays: pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1241287 & 1241003).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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.A complaint history review was performed by subject lot numbers (1241287 & 1241003) for similar events, going back 12 months from notification date, and there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.January post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device (ilrghg x 2).Based on the available information, device malfunction could not be verified as the exact details of the reported event was non-verifiable and the product was not returned.The following sections have been updated: b4: date of this report; g3: date received by manufacturer; g6: checked "follow-up"; h2: checked follow-up type; h3: changed "yes" to "no"; h6: entered evaluation codes; h10: added manufacturer narrative h3 other text : device not returned.

• Brand Name: CERTAIN¿ GOLD-TITE¿ LARGE HEXED SCREW
• Common Device Name: DENTAL SREW
• 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: 15693777
• Report Number: 0001038806-2022-01646
• Device Sequence Number: 2905114
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)251105(10)1241287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K972444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/05/2025
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1241287
• Was Device Available for Evaluation?: No
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2020
• 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
• Patient Age: 70 YR
• Patient Sex: Female