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

Model Number	BOES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that following implant placement, unable to remove mount from implant.Implant was removed.Procedure was completed using another implant.As a result of this event, no injury to the patient reported.Symptoms as a result of the event: none reported.Tooth location not reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) 3i t3â® short external hex parallel walled implant, 5mm(d) x 5mm(l) (boes505) was returned for investigation.Visual evaluation of the as returned product identified one (1) boes505 implant with bundled mount, cover screw and label/vial returned with signs of use.The implant and mount were returned not fully attached (gap visible at hex).Functional testing determined the implant and bundled mount could easily be separated.Additionally, the implant and mount were able to be properly assembled.An additional mount (icg03cy-q) was returned with signs of use and no apparent malfunction.The additional mount also was able to be properly assembled to the implant.A follow up was created for the additional bundled mount to determine if a failure was reported for it or if it was returned after being used with the other implant placed in the procedure.No pre-existing condition was noted, and no per form was provided.Bone density type is unknown.The reported device was located on an unknown tooth site, and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2020011265).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 number (2020011265) for similar events and no other complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.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.

• Brand Name: 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(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: 13129645
• Report Number: 0001038806-2021-02439
• Device Sequence Number: 14579289
• Product Code: DZE
• UDI-Device Identifier: 00844868033639
• UDI-Public: (01)00844868033639(17)250220(10)2020011265
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 02/20/2025
• Device Model Number: BOES505
• Device Catalogue Number: BOES505
• Device Lot Number: 2020011265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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