MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 4MM(H); DENTAL ABUTMENT

Model Number	ILPAC3417
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment was fractured off in the implant.The fractured abutment piece has been removed from the implant and the implant is intact and no damage reported.Tooth # 4.
Event or Problem Description
No additional event information 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.D9: device availability and return date 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: component code was added: 4755.H6: tyoe of investigation codes were added: 4109, 4111, 4110 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.One certain® low profile 17° abutment 3.4mm(d) x 4mm(h) (ilpac3417) was returned for investigation.Visual evaluation of the as returned product identified that the abutment fractured on the middle connection, however, no apparent malfunction with the screw identified.Based on the evaluation, device malfunction has occurred.However, 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 device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (2020060192).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Complaint history review was completed for the subject lot number (2020060192) for functional fracture category through complaint history review and no other complaint was identified.Functional testing could not be performed since the device was fractured.Therefore, the reported event couldn't be recreated.A definitive root cause could not be identified.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation are excessive torque during placement and cross threaded.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11769506
• Report Number: 0001038806-2021-00740
• Device Sequence Number: 19894842
• Product Code: NHA
• UDI-Device Identifier: 00844868037545
• UDI-Public: (01)00844868037545(17)250629(10)2020060192
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 06/29/2025
• Device Model Number: ILPAC3417
• Device Catalogue Number: ILPAC3417
• Device Lot Number: 2020060192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1