MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 6.0MMD, 8MML; DENTAL IMPLANT

Catalog Number	TSX6B8
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D6a: implant date unknown / not provided.D6b: explant date unknown / not provided.E1: last name unknown / not provided.
Event or Problem Description
It was reported implant stripped in the internal hex during placement was able to complete placement by hand wrenching or with motor.The implant was removed and replaced in the same surgery.
Additional Manufacturer Narrative
Zimvie received one (1) tsx6b8 (tsx implant, 6.0mmd, 8mml) for evaluation.Visual evaluation was performed.Damaged threads due to the removal process.Damaged drive feature has been identified.Dhr review was completed for the subject lot number 2120016376.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 2120016376 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz rev 12, the most likely root cause determined from the investigation was torque or speed applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.Implant drive feature was observed to be damaged.The reported event was confirmed.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.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.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: TSX IMPLANT, 6.0MMD, 8MML
• Common Device Name: DENTAL IMPLANT
• 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: 21860468
• Report Number: 0001038806-2025-00827
• Device Sequence Number: 17323256
• Product Code: DZE
• UDI-Device Identifier: 00844868045328
• UDI-Public: (01)00844868045328(17)290730(10)2120016376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• 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): 07/15/2025

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 Catalogue Number: TSX6B8
• Device Lot Number: 2120016376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• 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: 04/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: Unknown
• Patient Ethnicity: Non Hispanic