MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H); DENTAL ABUTMENT

Model Number	ILPC344U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Expiration date unknown / not provided.
Event or Problem Description
The doctor reports that while he was screwing the abutment, it has broken and confirms that another abutment has been used to complete the dental surgical procedure.The affected dental position is #32.The doctor also confirms that the patient did not suffer any kind of impact with his health.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) one certain® low profile one-piece abutment 3.4mm(d) x 4mm(h) (ilpc344u) was returned for investigation.Visual evaluation of the as returned product identified that abutment screw fractured at the threads.Functional testing could not be performed since the device was fractured.Device history record (dhr) review was completed for the subject lot number 2018032207.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (2018032207) was performed for similar event using keyword category fracture screw and no other similar complaints were identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12588326
• Report Number: 0001038806-2021-01902
• Device Sequence Number: 3067762
• Product Code: NHA
• UDI-Device Identifier: 00844868021087
• UDI-Public: (01)00844868021087(17)230417(10)2018032207
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 04/17/2023
• Device Model Number: ILPC344U
• Device Catalogue Number: ILPC344U
• Device Lot Number: 2018032207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2018
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG