MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL DRIVER

Catalog Number	IIPDTUL
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.B3: date of event: unknown / not provided.
Event or Problem Description
The doctor reports that the instrument became embedded with the implant, making it impossible to separate them.Procedure completed.Affected tooth position = 27.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d4: additional device information -expiration date in blank, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) iipdtul, (internal connection universal placement driver tip - long) for evaluation.Visual evaluation of the as returned devices identified the driver with signs of use.The driver was observed attached to the implant, and during a functional / physical test the driver did not disengage/release from the implant as intended.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 1290423.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 1290423 for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release based on the investigation and risk management file review, the most likely root causes determined from the investigation are incorrect techniques used, excessive torque applied.Therefore, based on the available information and functional testing, a 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.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.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d4: additional device information -expiration date in blank, d4: unique identifier (udi) number updated, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) iipdtul, (internal connection universal placement driver tip - long) for evaluation.Visual evaluation of the as returned devices identified the driver with signs of use.The driver was observed attached to the implant, and during a functional / physical test the driver did not disengage/release from the implant as intended.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 1290423.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 1290423 for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release based on the investigation and risk management file review, the most likely root causes determined from the investigation are incorrect techniques used, excessive torque applied.Therefore, based on the available information and functional testing, a 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.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Common Device Name: DENTAL DRIVER
• 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: 22903525
• Report Number: 0001038806-2025-02033
• Device Sequence Number: 8001327
• Product Code: NDP
• UDI-Device Identifier: 00844868038870
• UDI-Public: (01)00844868038870(11)241024(10)1290423
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: Other
• Device Catalogue Number: IIPDTUL
• Device Lot Number: 1290423
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2025
• 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: 08/27/2025
• Supplement Report FDA Received Date: 10/16/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic