MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOCATOR® ABUTMENT 4.1MM(D) X 5MM(H); DENTAL ABUTMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to report zimmer biomet (b)(4).0001038806-2019-01677 has also been submitted.The reported device has been received for investigation.Investigation has not begun.Once investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the abutment fractured at the upper level.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.D4: expiration date is unknown.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H4: device manufacturer date is unknown h6: method code was updated to 10.H6: results code was updated to 3252.H6: conclusions code was updated to 4307.H10: narrative/data was updated.The reported device was returned to the manufacturer zest for evaluation.The reported condition of a fractured abutment was confirmed.Visual inspection identified that the abutment has rough wear (visible striations or deep grooves) at the coronal surfaces; it appears that the clinician shaved one coronal edge on the abutment in order to remove the abutment, since the drive feature was rounded / damaged.The abutment broke at the post minor thread.There is no manufacturing defect noted.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was not completed since no zest lot number was provided by the customer.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: CERTAIN® LOCATOR® ABUTMENT 4.1MM(D) X 5MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9506960
• Report Number: 0001038806-2019-01679
• Device Sequence Number: 1410609
• Product Code: DZE
• UDI-Device Identifier: 00844868006107
• UDI-Public: (01)00844868006107(17)180416(10)1141996(241)ILOA005
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K012911
• 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): 02/19/2020

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 Model Number: N/A
• Device Catalogue Number: ILOA005
• Device Lot Number: 1141996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 67 YR