MAUDE Adverse Event Report: BIOMET 3I EP® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H); DENTAL HEALING ABUTMENT

Model Number	THA53
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the groove where the drivers goes in the healing abutment was deformed, the tip of the driver does not adjust.Procedure was completed using a another healing abutment and same driver.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient weight: weight unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem d4: expiration date g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' *h4: device manufacture date h6: evaluation codes h10: additional narrative one healing abutment and one unknown biomet driver were reported but only the abutment was returned for investigation (see images attached to complaint).Visual evaluation of the as returned product identified damaged abutment drive feature (top).Functional testing could not be performed due to the nature of the devices and events.No pre-existing conditions were reported.The reported device had been place on tooth #24 (universal) for an unknown period of time.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Instructions for use for biomet 3i kits and instruments (p-zbdinstrp), rev e 2022/04/01.Per the applicable ifu, it is stated that improper technique can lead to device failure.Additionally, breakage may occur when device is loaded beyond its functional capability.Dhr review: dhr review for the lot (1236789) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Dhr could not be reviewed for the unknown driver since the lot number was unknown.Complaint history review: complaint history review was performed for the reported lot number (1236789) for similar events (complaint category keywords: does not seat & damaged drive feature) and no other complaint was identified.A complaint history review by item number was conducted for the tha53 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/ capa/hhe/d /ie/product holds for the reported product for similar events (complaint category keyword: does not seat & damaged drive feature).Post market trending review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, device malfunction did occur for the abutment and the reported event (damaged drive feature) was confirmed.

• Brand Name: EP® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
• Common Device Name: DENTAL HEALING 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: 13885565
• Report Number: 0001038806-2022-00395
• Device Sequence Number: 884322
• Product Code: NHA
• UDI-Device Identifier: 00844868016946
• UDI-Public: (01)00844868016946(17)250318(10)1236789
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 03/18/2025
• Device Model Number: THA53
• Device Catalogue Number: THA53
• Device Lot Number: 1236789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female