MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 6MM(H); DENTAL HEALING ABUTMENTS

Model Number	IWTH56
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during uncovering, the healing abutments did not seat.No impact to the patient reported.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
No further event information is available at the time of the report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative two healing abutments (iwth56 and imha36) were returned for investigation.Visual evaluation of the as returned products identified no malfunction/damages.Functional testing was performed using in-house mating device and no malfunction was identified.Additionally, measurements were taken using a caliper.Through dimensional analysis and comparison to drawings, the devices were determined to be within design specifications.Device history record (dhr) review for the lots (1248387 and 1249645) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lots (1248387 and 1249645) for similar events and no other complaint about nonconforming products was identified.Therefore, based on the available information and functional testing, device malfunction has not occurred and the reported event has been unconfirmed.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 6MM(H)
• Common Device Name: DENTAL HEALING ABUTMENTS
• 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: 13974136
• Report Number: 0001038806-2022-00471
• Device Sequence Number: 4789460
• Product Code: NHA
• UDI-Device Identifier: 00844868009191
• UDI-Public: (01)00844868009191(17)260929(10)1248387
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/25/2022

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: 09/29/2026
• Device Model Number: IWTH56
• Device Catalogue Number: IWTH56
• Device Lot Number: 1248387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Sex: Unknown