MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)

Model Number	IEHA454
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the healing abutment screw fractured at the site.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight not provided contact name and email address of reporter 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).One associated screw for a healing abutment was returned for investigation.Visual evaluation of the as returned product identified fracture around the threads.Functional testing could not be performed due to the nature of the device and event.No pre-existing conditions were noted in the per.The device was intended for tooth 36 and was in place for only 6 months.X-ray & picture evaluation: x-ray and picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: warnings and precautions.Per the applicable ifu, breakage/device failure may occur following improper techniques used and when device is loaded beyond its functional capability.Dhr review: dhr review for the lot (1253781) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (1253781) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.Post market trending review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: HEALING 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: 15152301
• Report Number: 0001038806-2022-01173
• Device Sequence Number: 5234462
• Product Code: NHA
• UDI-Device Identifier: 00844868004646
• UDI-Public: (01)00844868004646(17)270418(10)1253781
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072642
• 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): 12/09/2022

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 Model Number: IEHA454
• Device Catalogue Number: IEHA454
• Device Lot Number: 1253781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male