MAUDE Adverse Event Report: BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 6MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	BOES605
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Screw and mount sold bundled with implant.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during placement, the screw of the implant would not loosen to allow removal of the mount.Attempted multiple times, eventually stripping the screw head.The implant had to be removed and replaced with a different implant.Attempted to loosen the screw after the procedure using plyers, wrench to no avail.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was corrected/updated to 887 h6: health effect impact code was corrected/updated to 4604 h6: type of investigation codes were added: 10, 4110, 4109, 4111 and 3331.H6: investigation findings code was added: 180.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.One 3i t3® short external hex parallel walled implant, 6mm(d) x 5mm(l) (boes605) with mount was returned for investigation.Visual evaluation of the as returned implant identified signs of use and wear on the mount and screw (most likely from multiple attempts in order to remove screw).Functional testing was performed and mount could not be disengaged from the implant.Hence, the reported event was recreated.Pre-existing patient condition was type iii (low) bone density.The device was attempted to locate on tooth site #3 (fdi) and removed same day.Dhr review was completed for the subject lot number (2019090956).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 completed for the subject lot number (2019090956) for does not disengage/release category and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or products.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 6MM(D) X 5MM(L)
• 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: 12218775
• Report Number: 0001038806-2021-01365
• Device Sequence Number: 4136496
• Product Code: DZE
• UDI-Device Identifier: 00844868033653
• UDI-Public: (01)00844868033653(17)241022(10)2019090956
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 10/22/2024
• Device Model Number: BOES605
• Device Catalogue Number: BOES605
• Device Lot Number: 2019090956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• 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: 07/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT MOUNT; IMPLANT SCREW; IMPLANT MOUNT; IMPLANT SCREW
• Patient Age: 71 YR
• Patient Sex: Male