MAUDE Adverse Event Report: BIOMET 3I TSV¿¢ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H)

Model Number	TEHA3505
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment would not screw into the implant.It was not indicated if the procedure was completed using another device.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient id: patient id not provided.Age or date of birth: patient age not provided.Weight: patient weight not provided date of event: date of event.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) tsv bellatekâ® encodeâ® healing abutment 3.5mm (d) x 5.0mm (p) x 5mm (h) (teha3505) was returned for investigation.Visual evaluation of the as returned product identified the abutment without original packaging, inside an auto clave bag.Signs of use around screw threads.The abutment seated and screwed as intended during a functional test, with an in-house implant.The coob is non-verifiable since, the condition of the product when it was received by the customer, is unknown/non-verifiable.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site (universal) and was used.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: tsv¿ bellatek® encode® healing abutment p-tsvbeha 2022/02 rev d.Information identified: warnings, precautions and potential adverse events.Dhr review: dhr review was completed for the subject lot number (1246779).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 was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (1246779) for similar events and no other complaint was identified.Review completed utilizing keywords: does not seat post market trend review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (teha3505).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.Sections updated: b4: date of this report g3: date investigation results were received g6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event problem codes h10: manufacturer's narrative.

• Brand Name: TSV¿¢ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (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: 13934203
• Report Number: 0001038806-2022-00441
• Device Sequence Number: 4844191
• Product Code: NHA
• UDI-Device Identifier: 00844868040934
• UDI-Public: (01)00844868040934(17)260721(10)1246779
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173374
• 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): 09/13/2022

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: 07/21/2026
• Device Model Number: TEHA3505
• Device Catalogue Number: TEHA3505
• Device Lot Number: 1246779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: Prefer Not To Disclose