MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE 17° ABUTMENT 4.1MM(D) X 4MM(H); DENTAL ABUTMENT

Model Number	ILPAC4417
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Fax number name unknown / not provided.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Doctor indicated a fractured healing abutment.The abutment was removed and another healing abutment was placed.
Additional Manufacturer Narrative
Based on additional information and device evaluation, the abutment and/or screw was not fractured.The screw was damaged during removal.There was no injury, significant delay and no alleged failure of the device.Therefore, this event does not meet the definition of a reportable event.Zimmer biomet complaint number cmp-(b)(4).This report is being submitted to relay corrected information for the initial report.Based on additional information, this event is not reportable.The following sections are being reported: b5: description of event was updated/corrected.B4: date of this report was updated.D9: device availability and return date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: additional narrative/data was updated.One certain® low profile 17° abutment 4.1mm(d) x 4mm(h) (ilpac4417) and associated screw were returned for investigation.Visual evaluation of the as returned products identified that the screw hex was damaged (stripped and rounded).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
During follow-up, the customer confirmed that the screw was not fractured, it was just damaged while trying to be removed.

• Brand Name: CERTAIN® LOW PROFILE 17° ABUTMENT 4.1MM(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: 12800689
• Report Number: 0001038806-2021-02178
• Device Sequence Number: 4778427
• Product Code: NHA
• UDI-Device Identifier: 00844868037569
• UDI-Public: (01)00844868037569(17)210125(10)2016011141
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: ILPAC4417
• Device Catalogue Number: ILPAC4417
• Device Lot Number: 2016011141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female