MAUDE Adverse Event Report: BIOMET 3I TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 5MM(H); DENTAL HEALING ABUTMENT

Catalog Number	TEEHA465
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Multiple reports are being submitted for this event.
Event or Problem Description
It was reported that the abutments placed in site 18 would not seat, kept spinning.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Multiple reports are being submitted for this event.The following sections are being reported: d4: expiration date and unique identifier (udi) number h2: if follow-up, what type h3: device evaluated by manufacturer h4: device manufacturer date h6: type of investigation h6: investigation findings h6: investigation conclusions h10: additional narratives/data zimvie received one healing abutment for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use, and slight wear however, the abutment engaged/seats as intended with an in-house zimmer implant during a functional test.No malfunction.Dhr review was completed for the subject lot number.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 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 incorrect techniques used - customer error.Therefore, based on the available information, and functional testing a device malfunction did not occur.The reported event was non-verifiable with all the available information and without return of all devices involved.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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 5MM(H)
• Common Device Name: DENTAL HEALING 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: 19588802
• Report Number: 0001038806-2024-01306
• Device Sequence Number: 11598173
• Product Code: NHA
• UDI-Device Identifier: 00844868045885
• UDI-Public: (01)00844868045885(17)271003(10)1258558
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K212730
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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: TEEHA465
• Device Lot Number: 1258558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic