MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Catalog Number	ILPC442
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported the screw of the low profile abutment fractured.Fracture portion was removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One certain® low profile abutment 4.1mm(d) x 2mm(h), ilpc442 was returned for investigation.Visual inspection via naked eye and camera magnification revealed abutment screw fractured at threads.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Per: no pre-existing conditions were noted on the per form provided.Bone density type is type ii.The reported device was located on tooth site 24 (fdi) and length of use is unknown.Picture/x-rays: pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: 'precautions' 'breakage' 'warning' per the applicable ifu, it is stated that improper technique can lead to device failure.Additionally, breakage may occur when device is loaded beyond its functional capability.Dhr review: dhr review could not be performed for the ilpc442 as the lot number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review: a complaint history review by item number was conducted for the ilpc442 dating back to 12 months from the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keywords: fracture screw.Post market trend review: february post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device (ilpc442).Malf/event: based on the available information, device malfunction did occur and the reported event was confirmed following inspection and evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(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: 12842906
• Report Number: 0001038806-2021-02212
• Device Sequence Number: 11131614
• Product Code: NHA
• 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): 05/06/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ILPC442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male