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

Catalog Number	IMHA34
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient age and weight not provided/ unknown.Event date not provided/unknown.Device lot number not provided/unknown.
Event or Problem Description
It was reported that the abutment had trouble seating onto the implant in the patient's mouth.Customer requested to change abutments.
Additional Manufacturer Narrative
One healing abutment was returned for investigation.Visual evaluation of the as returned product identified minor nicks and signs of wear due to usage around the post and the drive feature.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.Functional testing was performed using an in-house implant.The device could not seat on the implant.The alleged device malfunction was confirmed.A root cause cannot be determined.The following sections have been updated: h3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® EP® 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: 9707699
• Report Number: 0001038806-2020-00336
• Device Sequence Number: 10659358
• Product Code: NHA
• Combination Product (Y/N): N
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 01/01/2017
• Device Catalogue Number: IMHA34
• Device Lot Number: 1064883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1