MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOCATOR ABUTMENT 3.4MM(D) X 6MM(H); DENTAL ABUTMENT

Model Number	IMLOA006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the locator screw fractured.Fractured part of the locator was removed from the implant.
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.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.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.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 hazard experience:thread fracture during function.And most likely root cause of the failure mode / hazard:typically is the result from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.Known issue is being tracked and trended with no further actions taken at this time.

• Brand Name: CERTAIN LOCATOR ABUTMENT 3.4MM(D) X 6MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10512972
• Report Number: 0001038806-2020-01346
• Device Sequence Number: 17028875
• Product Code: DZE
• UDI-Device Identifier: 00844868006367
• UDI-Public: (01)00844868006367(17)240827(10)1231815(241)IMLOA006
• 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): 11/30/2020

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: Health Professional
• Device Expiration Date: 08/27/2024
• Device Model Number: IMLOA006
• Device Catalogue Number: IMLOA006
• Device Lot Number: 1231815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR