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

Model Number	ILOA004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment fractured at the thread level.An addition procedure was required to remove the fractured part from the implant.Doctor has placed a provisional abutment would place a new locator.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The complaint report was received, reviewed, and evaluated by the manufacturer's complaint process.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.Applicable manufacturer's 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 manufacturer's 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.As part of each complaint investigation, the manufacturer 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, the manufacturer has concluded the following as the root-cause or most likely root-cause of the reported complaint condition: no manufacturing defect was found.Most likely (see below): hazard experience: thread fracture during function.Most likely root cause of the failure mode / hazard: 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 is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d10: device available for evaluation change ¿no' to 'yes' g4: date received by manufacturer g7: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative the complaint report was received, reviewed, and evaluated by the manufacturer's complaint process.Applicable manufacturer's 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 manufacturer's 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.As part of each complaint investigation, the manufacturer 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, the manufacturer has concluded the following as the root-cause or most likely root-cause of the reported complaint condition: the reported complaint condition cannot be verified.No physical evaluation can be performed as product was not received by the manufacturer at this time.The manufacturer was unable to find evidence of a manufacturing issue per current records, and believes that the components do not present any manufacturer errors.

• Brand Name: CERTAIN LOCATOR ABUTMENT 4.1MM(D) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10834939
• Report Number: 0001038806-2020-01820
• Device Sequence Number: 14455842
• Product Code: DZE
• UDI-Device Identifier: 00844868006091
• UDI-Public: (01)00844868006091(17)250616(10)1237960(241)ILOA004
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2021

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: 06/16/2025
• Device Model Number: ILOA004
• Device Catalogue Number: ILOA004
• Device Lot Number: 1237960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 02/10/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/03/2021; 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR