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

Model Number	IEHA454
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the screw portion of a healing abutment at tooth #30 has fractured off.Delay was 30 min to complete scheduled procedure.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The complaint reported that the screw portion of the abutment had fractured off.The product was returned and the reported event was confirmed following visual evaluation.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance/capa/hhe/d/ie/product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot (1207968) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot (1207968) and no similar event or complaint was identified.Functional testing could not be performed since the device was fractured.Therefore, the reported event couldn't be recreated.A definitive root cause could not be identified.However, based on the investigation, risk review and ifu, the potential cause for the reported event is incorrect engagement of abutment screw to implant and/or occlusal loading.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11350826
• Report Number: 0001038806-2021-00288
• Device Sequence Number: 3343978
• Product Code: NHA
• UDI-Device Identifier: 00844868004646
• UDI-Public: (01)00844868004646(17)220801(10)1207968(241)IEHA454
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 08/01/2022
• Device Model Number: IEHA454
• Device Catalogue Number: IEHA454
• Device Lot Number: 1207968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1