MAUDE Adverse Event Report: BIOMET 3I 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	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).Reporter first name not provided.Reporter email address not provided.The reported device has been received for evaluation.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 locator abutment fractured.All fractured pieces were removed.There is no report of patient injury.
Additional Manufacturer Narrative
Fracture pieces of the zest dental locator abutment were received for investigation.The received locator abutment returned without original package; therefore, it was unbale to verify zest lot number information.Visual inspection was performed for as a retuned product and it was noted that abutment has smooth wear at the coronal surfaces and a fracture was noted at the post minor thread.No manufacturing defect was noted.Dhr review and complaint history review could not be performed by zest dental solutions since no zest lot number was provided by the customer.Therefore, based on the evaluation, the malfunction had occurred, thread fracture was identified during function and this report was confirmed following inspection.A definitive root cause could not be identified by zest dental solutions.However, thread fracture during function typically results from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 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: 8712161
• Report Number: 0001038806-2019-00543
• Device Sequence Number: 2298884
• Product Code: DZE
• UDI-Device Identifier: 00844868009573
• UDI-Public: (01)00844868009573(17)220629(10)1208190(241)LOA005
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/04/2019

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: LOA005
• Device Lot Number: 1208190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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