MAUDE Adverse Event Report: BIOMET 3I LOCATOR® ABUTMENT 4.1MM(D) X 4MM(H); DENTAL SCREW

Model Number	LOA004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.
Event or Problem Description
It was reported that locator was fractured in the implant.Clinician indicated that the fractured portion was removed from the implant and a new locator was placed.No delay or injury.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zest quality assurance has conducted an investigation into the complaint reported by your company which included the below elements, as indicated.The complaint report was received, reviewed, and evaluated by the zest dental solutions complaint process in compliance with applicable fda and ous country regulations.Applicable zest internal lot history records were reviewed to evaluate whether any internal deviations, non-conformances, or problems occurred during the manufacture of the lot, which could cause or contribute to the reported complaint condition.A review of other zest complaint files and related trending data for similar incidents was performed to evaluate whether other similar complaints have been received and if data suggests any adverse trends may have contributed to the complaint root cause.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.If applicable and if available, retained product or product remaining in stock was evaluated to confirm the reported product complaint.Condition of the returned complaint related equipment was evaluated by repair technician to confirm the reported complaint and assess needed repairs (if any).As part of each complaint investigation, zest performs an analysis to determine the root-cause of the reported problem.Depending upon the information provided, a true root-cause may or may not be determined.In these cases, the most-likely cause of the reported issue would be determined.Other known issues that are inherent to the business operations, typically ones that are related to shipping, handling, customer service, or other, are internally tracked and continually trended for unusual increases.As a result of the above investigation, zest has concluded the following as the root-cause or most likely root-cause of the reported complaint condition: root-cause or most likely root-cause cannot be determined based upon the information provided.No manufacturing defect was found.The reported complaint condition cannot be verified.

• Brand Name: LOCATOR® ABUTMENT 4.1MM(D) X 4MM(H)
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10053657
• Report Number: 0001038806-2020-00769
• Device Sequence Number: 3293464
• Product Code: DZE
• UDI-Device Identifier: 00844868009566
• UDI-Public: (01)00844868009566(17)231121(10)1222992(241)LOA004
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 06/26/2020

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: 11/21/2023
• Device Model Number: LOA004
• Device Catalogue Number: LOA004
• Device Lot Number: 1222992
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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