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

Model Number	ITHA54
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment fractured at 20 ncm torque.The remaining portion of the abutment was removed and a new provisional abutment placed and torqued without a problem.Tooth #30.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
Product evaluation: 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.Functional testing could not be performed since the device was fractured.Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported device was intended for tooth # 30 (universal).Review of appropriate documentation: 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: dhr review for the lot (1240683) 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: complaint history review was performed for the reported lot number (1240683) for similar events (complaint category keywords: fracture) and no other complaint was identified.Post market trending review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.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: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11585850
• Report Number: 0001038806-2021-00521
• Device Sequence Number: 19572230
• Product Code: NHA
• UDI-Device Identifier: 00844868008392
• UDI-Public: (01)00844868008392(17)251025(10)1240683
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 10/25/2025
• Device Model Number: ITHA54
• Device Catalogue Number: ITHA54
• Device Lot Number: 1240683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR