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

Model Number	ILPC343U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that implant had to be removed due to screw fracture inside.Procedure was completed with other implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No further event information is available at the time of this report.Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: 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 one certain® low profile one-piece abutment (ilpc343u) and one 3i t3® non-platform switched tapered implant (bost3211) were returned for investigation.Visual evaluation of the as returned products identified the abutment screw portion was fractured.Additionally, screw fragment was identified inside the implant and bone/blood residue was identified around the external threads.Functional testing could not be performed due to the nature of the devices and event.Device history record review for the lot (2020030799) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.A complaint history review by item number was conducted for the lot (2020030799).The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported products for similar events (complaint category keyword: functional: fracture: screw).June post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.Additionally, screw fragment was stuck in the implant drive feature.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)
• Common Device Name: DENTAL ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11824231
• Report Number: 0001038806-2021-00807
• Device Sequence Number: 14456843
• Product Code: NHA
• UDI-Device Identifier: 00844868021094
• UDI-Public: (01)00844868021094(17)250422(10)2020030799
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/22/2025
• Device Model Number: ILPC343U
• Device Catalogue Number: ILPC343U
• Device Lot Number: 2020030799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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