MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL SCREW

Model Number	ILPC341
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reported the screw fractured and removed.
Event or Problem Description
Based on product returned, the abutment is not fractured.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
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).Two low profile abutment gold-tite® retaining screws (lpcgsh x2), one certain® low profile 30° abutment (ilpac3330) and one certain® low profile abutment (ilpc341) were returned for investigation.Visual evaluation of the as returned products identified fractured fragments of the retaining screws on top of the abutments, and the ilpac3330 was fractured as well.Device history record (dhr) review was completed for the subject lot numbers (2017080218, 2017090491 &1211303).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was completed for the subject lot numbers (2017080218, 2017090491 &1211303) and no complaints about nonconforming products were identified.Therefore, based on the available information, device malfunction did occur and the reported ¿screw fracture was confirmed.Additionally, an unreported malfunction (abutment fracture) was also identified during investigation.

• Brand Name: CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 1MM(H)
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10790830
• Report Number: 0001038806-2020-01738
• Device Sequence Number: 1128454
• Product Code: NHA
• UDI-Device Identifier: 00844868021162
• UDI-Public: (01)00844868021162(17)220928(10)2017090491(241)ILPC341
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2021

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: Lay User/Patient
• Device Expiration Date: 09/28/2022
• Device Model Number: ILPC341
• Device Catalogue Number: ILPC341
• Device Lot Number: 2017090491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/29/2021; 02/22/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/18/2021; 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1