MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H)

Model Number	ILPC341U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).
Event or Problem Description
It was reported that the abutment screw fractured.The implant in dental site 12 is in good condition.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One abutment screw was returned for investigation.Visual evaluation of the as returned abutment identified signs of wear from use, and the drive feature contains the fractured piece of the screw.The piece was too badly damaged to be removed.The screw head was worn from use and fractured at the threads.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.The alleged device malfunction was confirmed.A root cause cannot be determined.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.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H)
• Common Device Name: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9681006
• Report Number: 0001038806-2020-00285
• Device Sequence Number: 14306414
• Product Code: NHA
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)240710(10)2019060917(241)ILPC341U
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: Lay User/Patient
• Device Expiration Date: 07/10/2019
• Device Model Number: ILPC341U
• Device Catalogue Number: ILPC341U
• Device Lot Number: 2019060917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 80