MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H); DENTAL ABUTMENT

Model Number	IWTH573
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was missing a healing abutment during a implant stability test.It is unknown when it became missing.
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 3331, 4109, 4110, 4111, 4114.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.H10: narrative/data was updated.One certain® ep® healing abutment 5mm(d) x 7.5mm(p) x 3mm(h) (iwth573) was reported but not returned for investigation.Based on the evaluation, device malfunction could not be verified for the abutment.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the products were within specifications and conforming when they left zimvie.Dhr review for the lot (1240286) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.Complaint history review was performed for the reported lots number (1240286) for similar events and no other complaint were identified.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation improper techniques used or failure to follow recommended protocol for implant placement.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H)
• Common Device Name: DENTAL 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: 15221619
• Report Number: 0001038806-2022-01261
• Device Sequence Number: 5746443
• Product Code: NHA
• UDI-Device Identifier: 00844868009269
• UDI-Public: (01)00844868009269(17)251011(10)1240286
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: Lay User/Patient
• Device Expiration Date: 10/11/2025
• Device Model Number: IWTH573
• Device Catalogue Number: IWTH573
• Device Lot Number: 1240286
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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 Age: 50 YR
• Patient Sex: Unknown