MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H); DENTAL ABUTMENT

Catalog Number	ILPC343U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment fractured at the screw of the abutment and was removed.Procedure was completed with other item.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient identifier unknown/not provided.Age and date of birth unknown/not provided.Patient sex unknown/not provided.Weight unknown/not provided.
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).Zimvie received one (1) ilpc343u, (certain low profile one-piece abutment 3.4mm(d) x 3mm(h)) for evaluation.Visual evaluation was performed, a fracture has been identified at the threads.Dhr review was completed for the subject lot number 2022100424.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022100424 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation were missing or confusing instructions for use and clinician incorrectly engages abutment screw into implant.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the threads.The reported event was confirmed.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)
• Common Device Name: DENTAL 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: 16731852
• Report Number: 0001038806-2023-00719
• Device Sequence Number: 6440840
• Product Code: NHA
• UDI-Device Identifier: 00844868021094
• UDI-Public: (01)00844868021094(17)271103(10)2022100424
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K092341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023
• 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: Other
• Device Catalogue Number: ILPC343U
• Device Lot Number: 2022100424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic