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

Model Number	IIPDTUL
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight unknown / not provided.Pma/510(k) number unknown / not provided.
Event or Problem Description
It was reported that brand new hex driver got stuck during implant placement, new implant placed right away with spare implant and driver.Tooth location # 14.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One 3i t3® tapered implant 5/4 x 8.5mm (bopt5485) and one internal connection universal placement driver tip ¿ long (iipdtul) was returned for investigation.Visual evaluation of the as returned products identified that they were engaged into each other.Functional testing was performed and the devices were determined to be stuck to each other.Pre-existing patient conditions, tooth location and x-ray images are irrelevant to this investigation.Pictures were not provided and no other information was provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot numbers (1232169 & 2019020445).It was confirmed that all operations and inspections were executed as per applicable procedures.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 numbers (1232169 & 2019020445) for similar events and no other complaint was identified.Based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.The following sections have been updated: g6: checked "follow-up." h3: changed "no" to "yes.".

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Common Device Name: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11864596
• Report Number: 0001038806-2021-00887
• Device Sequence Number: 3172574
• Product Code: NDP
• UDI-Device Identifier: 00844868038870
• UDI-Public: (01)00844868038870(17)240908(10)1232169
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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 Expiration Date: 09/08/2024
• Device Model Number: IIPDTUL
• Device Catalogue Number: IIPDTUL
• Device Lot Number: 1232169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR