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

Model Number	ISHA44
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight is not provided / unknown.
Event or Problem Description
It is reported that the healing abutment isha44 did not seat in the implant.Doctor did seat another healing abutment in the implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One certain® implant lab analog 4.1mm(d) (iila20) and one certain® twist lock tm coping 4.1mm(d) x 4.1mm(p) (iiic44) were returned for investigation.The reported certain® straight healing abutment 4.1mm(d) x 4.1mm(p) x 4mm(h) (isha44) and 3i t3® non-platform switched tapered implant 4 x 13mm (bost413) were not returned for inspection.Visual inspection of the as returned product identified minimal wear from use about the analog body and drive feature.The coping body and screw are likewise minimally worn.Functional testing was performed for the returned product and it was determined that the coping and analog returned assemble and seat with one another.These components were also tested with in house devices, and found to function as intended.It is noted that the patient has a history of clenching and bruxism, which could contribute to damage at the seating surface of the implant and/or abutment.The reported product was located on tooth # 5 and the implant remains implanted.The customer has not provided additional pictures or x-ray images of the product.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported they were trying two different abutments and they did not seat.The impression coping did not seat as well.Doctor seated a one piece healing abutment with force and a squeaking noise.Verification of the abutment and implant functionality could not be performed without product return.Therefore, the complaint could not be confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: b4: date of this report.D4: expiration date, udi.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes.' h4: device manufacture date.H6: evaluation codes.H10: additional narrative.

• Brand Name: CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9142168
• Report Number: 0001038806-2019-01136
• Device Sequence Number: 11498467
• Product Code: NHA
• UDI-Device Identifier: 00844868007883
• UDI-Public: (01)00844868007883(17)240617(10)1229402(241)ISHA44
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 06/17/2024
• Device Model Number: ISHA44
• Device Catalogue Number: ISHA44
• Device Lot Number: 1229402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR