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

Model Number	IIPDTUL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that during a guided surgery, the driver tip got stuck in the implant and broke off.The procedure was completed using another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified the implant with a driver tip stuck inside and does not disengage.No apparent fracture was noticed with the driver or the implant.The driver's iso-latch was seen worn out.The implant was measured using and matched the drawing specifications.Functional testing verified the implant did not disengage/release from the driver.No pre-existing conditions were noted on the product experience report (per) the patient's bone density type was not reported.The reported implant was located on tooth # 14 and was placed and removed on the same day.The reported iipdtul has been used for approximately 1 year.A device history record (dhr)review was performed and no related deviations or nonconformance's were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that during a guided surgery, the driver tip got stuck in the implant and broke off.The reported complaint was not confirmed.However, the driver was stuck to the implant.A definitive root cause for this complaint could not be determined.
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 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13734862
• Report Number: 0001038806-2022-00344
• Device Sequence Number: 11898246
• Product Code: NDP
• UDI-Device Identifier: 00844868038870
• UDI-Public: (01)00844868038870(10)1241843(241)IIPDTUL
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 12/03/2025
• Device Model Number: IIPDTUL
• Device Catalogue Number: IIPDTUL
• Device Lot Number: 1241843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male