MAUDE Adverse Event Report: BIOMET 3I CERTAIN 3.4MM(D) DRIVER TIP - LONG; DENTAL DRIVER

Catalog Number	IMPDTL
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 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.
Event or Problem Description
It was reported that all of the driver was getting stuck and spinning in the implant.The events occurred during different procedures, but they were able to complete them with no harm to patient or implant.The 3i implant driver's tip has been giving him issues during implant placement.At times, the driver tip will spin in the implant and other times the driver tip will get stuck in the implant.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) impdtl, (certain implant placement driver tip (long), 3.4mm(d)) for evaluation.Visual evaluation and functional testing were performed.Returned tool shows signs of wear and use.Tested with an in-house biomet implant and it engages, disengages and works as intended.Dhr review could not be performed since the lot number associated to the item was not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the impdtl dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: ¿dental: functional: device malfunction¿) the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00181-haz rev 7, the most likely root cause determined from the investigation was that was incorrect techniques used.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 therefore, based on the available information, a device malfunction has not occurred.Returned tool shows signs of wear and use, however, it was tested with an in-house biomet implant, and it engages, disengages and works as intended.The reported event has been unconfirmed.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.H3 other text: device was returned and investigated.

• Brand Name: CERTAIN 3.4MM(D) 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: 20657961
• Report Number: 0001038806-2024-02632
• Device Sequence Number: 15511779
• Product Code: NDP
• UDI-Device Identifier: 00844868038870
• UDI-Public: (01)00844868038870(17)290513(10)1282011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/20/2025

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: IMPDTL
• Device Lot Number: 1282011
• Was Device Available for Evaluation?: No
• 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; Not provided
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/21/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2024
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic