MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H); DENTAL SCREW

Model Number	ILPC444U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment fractured when trying to place it.It was impossible to remove the lower part of the abutment from within the implant and the implant had to be removed.Tooth location 15.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One certain low profile one-piece abutment 4.1mm(d) x 4mm(h) (ilpc444u) and one (1) 3i t3 non-platform switched tapered implant 6 x 10mm (bost610) were returned for investigation.Visual evaluation of the returned product identified that the abutment was fractured at the threads and the fractured piece was stuck inside the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition was not noted on the per form.Bone density was moderate density (type ii).The reported implant was located on tooth # 15 (fdi) and was used implanted and explanted on the same day.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019 information identified: 'warnings' 'precautions' 'potential adverse events'.Documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review: (ilpc444u): dhr review was completed for the subject lot number 2022100871.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 was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number 2022100871 for similar events and no other complaint was identified.Review completed utilizing keywords: 'dental : functional : fracture : screw'.Post market trend review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
• 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: 16397301
• Report Number: 0001038806-2023-00319
• Device Sequence Number: 6433329
• Product Code: DZE
• UDI-Device Identifier: 00844868021049
• UDI-Public: (01)00844868021049(17)271108(10)2022100871
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• 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): 05/24/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ILPC444U
• Device Catalogue Number: ILPC444U
• Device Lot Number: 2022100871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female