MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H); DENTAL SCREW

Catalog Number	ILPAC4330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment screw fractured during placement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) ilpac4330, (certain low profile 30 abutment 4.1mm(d) x 3mm(h)) and one (1) lpctsh (low profile abutment titanium retaining screw) for evaluation.Visual evaluation was performed, a fragment of screw was identified on top of the abutment.This complaint refers to the ilpac4330 device history record (dhr) review was completed for the subject lot number 2022110154.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022110154 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The retention screw was fractured inside the abutment.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) ilpac4330, (certain low profile 30 abutment 4.1mm(d) x 3mm(h)) and one (1) lpctsh (low profile abutment titanium retaining screw) for evaluation.Visual evaluation was performed, a fragment of screw was identified on top of the abutment.This complaint refers to the ilpac4330 device history record (dhr) review was completed for the subject lot number 2022110154.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022110154 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, the abutment screw for the ilpac4330 was not fractured.However, a device malfunction did occur for lpctsh.The retention screw was fractured inside the abutment.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
A fragment of an unknown screw was identified on top of the abutment.

• Brand Name: CERTAIN¿ LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H)
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17610984
• Report Number: 0001038806-2023-01617
• Device Sequence Number: 15346086
• Product Code: NHA
• UDI-Device Identifier: 00844868037613
• UDI-Public: (01)00844868037613(17)271128(10)2022110154
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K092341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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: Other
• Device Catalogue Number: ILPAC4330
• Device Lot Number: 2022110154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 02/14/2024; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic