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

Model Number	ILRGHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment screw fractured at the site.Abutment screw was removed and replaced.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Additional 510(k) number is k072642.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned abutments identified fractures at threads.No pre-existing conditions were noted on the product experience report (per).Patient was reported to have moderate density - (type ii) bone and the reported device was located on and tooth sites #25.Complainant reported that the abutment screw fractured at the site.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformance's were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.The following sections have been updated: h3: device evaluated by manufacturer; h6: evaluation codes; h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® GOLD-TITE® LARGE HEXED SCREW
• Common Device Name: ABUTMENT 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: 15162627
• Report Number: 0001038806-2022-01189
• Device Sequence Number: 17784454
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)260420(10)1244954
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 04/20/2026
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1244954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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
• Patient Sex: Female