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

Model Number	ILRGHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided, weight unknown / not provided, pma/510(k) number :k072642.
Event or Problem Description
It was reported that screws fractured and were removed patient had to return to place new screws.
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).Three (3) certain titanium large hexed screw (ilrght) & two (2) certain gold-tite large hexed screw (ilrghg) were returned for investigation.Visual evaluation of the as returned product identified signs of use.Two (2) gold screws were fractured at the threads, and three (3) titanium screws were also fractured at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.Patient is a smoker.The reported devices were located on tooth sites # 23, 26 (fdi) and were used for an unknown amount of time.Dhr review was completed for the subject lot numbers (1230367 & 1251766).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, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (1230367 & 1251766) for similar events and no other complaint was identified.Review completed utilizing keywords: fracture screw.Therefore, based on the available information, devices malfunction did occur, and the reported event was confirmed following visual inspection.

• Brand Name: CERTAIN GOLD-TITE LARGE HEXED SCREW
• 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: 15543173
• Report Number: 0001038806-2022-01507
• Device Sequence Number: 3290063
• Product Code: NHA
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)270119(10)1251766
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023
• 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 Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1251766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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: ILRGHT LOT 1230367 X3ILRGHG LOT 1251766
• Patient Age: 60 YR
• Patient Sex: Male