MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPC342U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).
Event or Problem Description
It was reported that while placing the abutment, it fractured at the screw portion.The screw could not be entirely removed from the implant, procedure was delayed by 30 minutes.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One osseotite® tapered certain® implant 3.25 x 13mm (int3213) was returned for investigation.Visual inspection of the as returned product identified signs of damage about the external threads.The internal drive feature is noted to contain a fractured threaded piece in the drive feature, which is noted to be the ilpc342u low profile abutment.This piece could not be disengaged from the drive feature.No pre-existing conditions were noted on the per.The reported product was located on tooth # 32 (fdi) and used for an unknown period of time.The reported event could not be recreated due to the nature of the dental device and event (fracture).Review of appropriate documentation: documents reviewed: zbinstsm rev.B 12/19; torque matrix - internal connection; page 8-9.Dhr review was completed for the subject lot number 2018031646.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2018031646) for similar event and no other complaint was identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event (component fracture) or product (int3213 & ilpc342u).Therefore, based on the available information, device malfunction has occurred.The returned implant could not disengage from the fractured piece.The reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11076918
• Report Number: 0001038806-2020-02128
• Device Sequence Number: 19515946
• Product Code: NHA
• UDI-Device Identifier: 00844868021100
• UDI-Public: (01)00844868021100(17)240716(10)2019070201(241)ILPC342U
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2024
• Device Model Number: ILPC342U
• Device Catalogue Number: ILPC342U
• Device Lot Number: 2019070201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75