MAUDE Adverse Event Report: BIOMET 3I CERTAINA® LOCATOR® ABUTMENT 3.4MM(D) X 5MM(H)

Model Number	IMLOA005
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).
Event or Problem Description
It was reported that the implant was removed due to a fracture.
Additional Manufacturer Narrative
Zest per # (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed by the manufacturer.No physical evaluation can be performed; therefore, no findings are available.Zest was unable to find evidence of a manufacturing issue per current records, and believes that the components do not present any manufacturer errors.The issue is being tracked and trended with no further actions taken at this time.It was reported that the screw of a locator abutment fractured.The reported complaint could not be verified.Root-cause or most likely root-cause cannot be determined based upon the information provided the following sections have been updated: d4: expiration date, udi.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H4: device manufacture date.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was reported that the locator abutment screw fractured.The implant system was not affected and remains implanted.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been corrected: b5: describe event or problem.

• Brand Name: CERTAINA® LOCATOR® ABUTMENT 3.4MM(D) X 5MM(H)
• Common Device Name: ABUTMENT
• 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: 14317655
• Report Number: 0001038806-2022-00646
• Device Sequence Number: 4586643
• Product Code: DZE
• UDI-Device Identifier: 00844868006350
• UDI-Public: (01)00844868006350(17)230815(10)1219349
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012911
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2022

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: 08/15/2023
• Device Model Number: IMLOA005
• Device Catalogue Number: IMLOA005
• Device Lot Number: 1219349
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 06/16/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/10/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2018
• 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 Sex: Unknown