MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)

Model Number	IEHA344
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the healing abutment could not be placed as it was defective.Sent follow up email to sales rep and customer to confirm defect.Procedure was completed using another device.Tooth location unknown.
Additional Manufacturer Narrative
A certain® bellatek® encode® healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h) (ieha344) was returned for investigation, see attached images a00 ¿ a03 in the complaint.Visual inspection of the as returned product identified worn markings due to usage.No damage.Functional testing was performed for the returned product with an in-house stock device and performed as intended.No malfunction identified when seating.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1236317).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1236317) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10774794
• Report Number: 0001038806-2020-01726
• Device Sequence Number: 19632277
• Product Code: NHA
• UDI-Device Identifier: 00844868004523
• UDI-Public: (01)00844868004523(17)250216(10)1236317(241)IEHA344
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: Health Professional
• Device Expiration Date: 02/16/2025
• Device Model Number: IEHA344
• Device Catalogue Number: IEHA344
• Device Lot Number: 1236317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention