MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 2MM(H)

Model Number	IMHA32
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the abutment became stuck on the implant resulting in implant removal.Tooth #19.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient weight not provided.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) certainâ® epâ® healing abutment 3.4mm(d) x 3.8mm(p) x 2mm(h) (imha32) & one (1) osseotite tapered certain implant 3.25 x 8.5mm (xifnt3285) were returned for investigation.Visual evaluation of the as returned product identified the abutment does not disengage from the implant.Malfunction.Functional testing to recreate the reported event verified the abutment is stuck to the implant and does not disengage/release.A pre-existing condition noted on the per was unknown bone density type.The reported devices were located on tooth # 19 (universal) and were used for approximately 5 months, 9 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-zbdinstrp), rev e 2022/04/01.Biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08/01.Information identified: warnings and precautions.Per the applicable ifu, breakage/device failure may occur following improper techniques used and when device is loaded beyond its functional capability.Dhr review: dhr review was completed for the subject lot numbers (1246684).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot numbers (1246684) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release post market trending review: aug post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (imha32).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, devices malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 2MM(H)
• Common Device Name: ABUTMENT
• 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: 14224800
• Report Number: 0001038806-2022-00585
• Device Sequence Number: 5232365
• Product Code: NHA
• UDI-Device Identifier: 00844868006251
• UDI-Public: (01)00844868006251(17)260806(10)1246684
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• 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): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/06/2026
• Device Model Number: IMHA32
• Device Catalogue Number: IMHA32
• Device Lot Number: 1246684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2021
• 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: XIFNT3285 2021010521
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female