MAUDE Adverse Event Report: BIOMET 3I CERTAIN EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H); DENTAL ABUTMENT (SCREW)

Model Number	ITHA54
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
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.Last/given name unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that while attempting to place a healing abutment in the patient's mouth, the screw portion fractured.The doctor was able to remove it without any damage to the implant.They were able to complete the procedure with another healing abutment.
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: h6: tyoe of investigation codes were added: 4109, 4110, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.One certain® ep® healing abutment 4.1mm(d) x 5mm(p) x 4mm(h) (itha54) was returned for investigation.Visual evaluation of the as returned product identified that the device was fractured at the threaded region (screw portion).Functional testing could not be performed since the device was fractured.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 for the lot (1241150) 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 zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1241150) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT (SCREW)
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11964580
• Report Number: 0001038806-2021-00961
• Device Sequence Number: 11865649
• Product Code: NHA
• UDI-Device Identifier: 00844868008392
• UDI-Public: (01)00844868008392(17)251220(10)1241150
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: Health Professional
• Device Expiration Date: 12/20/2025
• Device Model Number: ITHA54
• Device Catalogue Number: ITHA54
• Device Lot Number: 1241150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1