MAUDE Adverse Event Report: BIOMET 3I CERTAIN EP HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H); DENTAL ABUTMENT

Catalog Number	IMHA34
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided.D1: brand name unknown / not provided.D4: catalog and lot number unknown / not provided.D10: t3st3210, t3 pro non-platform switched tapered implant 3.25mm (d) x 10mm (l) g4: pma/510(k) number not available.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
It was reported that the healing cap fractured at the time of replacing after the fixture head impression was taken.The implant at tooth location #12 had to be removed.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D1: brand name was updated.D4: catalog number, lot number, expiration date and udi number were added.G3: date received by manufacturer was updated.G4: pma/510(k) number was updated.G7: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was updated.H10: narrative/data was updated.
Event or Problem Description
Additional information-the item number and lot number were provided.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.Zimvie received one (1) portion of the reported healing abutment for evaluation.Visual evaluation of the as returned device identified the fractured abutment's portion stuck inside the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 1247565.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 1247565 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are patient factors, clinician error.Therefore, based on the available information, device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: CERTAIN EP HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) 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 ; 5619713230
• MDR Report Key: 18210061
• Report Number: 0001038806-2023-02266
• Device Sequence Number: 15296983
• Product Code: NHA
• UDI-Device Identifier: 00844868006275
• UDI-Public: (01)00844868006275(17)260825(10)1247565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2026
• Device Catalogue Number: IMHA34
• Device Lot Number: 1247565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/01/2023; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic