MAUDE Adverse Event Report: BIOMET 3I EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H); DENTAL ABUTMENT

Catalog Number	THA56
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the healing abutment tha56 was attached to the fixture (nt), it was loose and could not be attached securely.Clinician was able to install it with another same tha56 without any problems.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tha56, (ep healing abutment 4.1mm(d) x 5mm(p) x 6mm(h)) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 1251062.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 1251062 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : does not seat.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was clinician damages screw surface (e.G.Scratches, dents resulting in removal of screw material).Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: h3: changed "yes" to "no".Device was not returned.
Additional Manufacturer Narrative
Zimvie received one (1) tha56, (ep healing abutment 4.1mm(d) x 5mm(p) x 6mm(h)) for evaluation.Visual evaluation was performed, and there was slight damage to the hex and functional testing with in-house implant did not allow for abutment to fully seat as intended.The coob is non-verifiable as the conditions of the product / packaging when delivered to the customer are unknown.Dhr review was completed for the subject lot number 1251062.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 1251062 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: fit: does not seat.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation was clinician damages screw surface (e.G.Scratches, dents resulting in removal of screw material).Therefore, based on the available information, a device malfunction did occur with damage to the hex of the abutment.Did not seat with in-house implant as intended.The reported event/coob could not be verified since the condition of the product/packaging when received by the customer was unknown.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report? d9: device availability? g3: date received by manufacturer? g6: checked "follow-up"? h2: checked follow-up type? h3: changed "no" to "yes"? h6: entered evaluation codes? h10: added manufacturer narrative?.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19923722
• Report Number: 0001038806-2024-01686
• Device Sequence Number: 7098493
• Product Code: NHA
• UDI-Device Identifier: 00844868016960
• UDI-Public: (01)00844868016960(17)270109(10)1251062
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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 Catalogue Number: THA56
• Device Lot Number: 1251062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 08/06/2024
• Supplement Report FDA Received Date: 09/06/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• 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 Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic