MAUDE Adverse Event Report: BIOMET 3I CERTAIN UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW; DENTAL SCREW

Model Number	IUNAB2T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain® ucla castable non-hexed cylinder 4.1mm(d) w/large dia.Ti screw ( unab2t) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fracture at thread.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 on the per.The reported device location is 36 and was used same day.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: ¿warnings¿ ¿precautions¿ ¿potential adverse events¿.Dhr review was completed for the subject lot number (1165327).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 was performed for the reported lot number (1165327) for similar event and no other complaint was identified.Post market trend review: december post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction has occurred and is confirmed as the product was found to be fractured.However, the reported event regarding improper design could not be verified through inspection of the returned device.
Event or Problem Description
It was reported that the castable screw on sites 36 was removed because the base is small and produces issues with the fixation.Doctor is awaiting replacement to complete the procedure.Upon investigation results, it was discovered tha the scew is fractured.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11384688
• Report Number: 0001038806-2021-00315
• Device Sequence Number: 17276132
• Product Code: NHA
• UDI-Device Identifier: 00844868008521
• UDI-Public: (01)00844868008521(10)1165327
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 03/15/2021

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: Health Professional
• Device Model Number: IUNAB2T
• Device Catalogue Number: IUNAB2T
• Device Lot Number: 1165327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR