MAUDE Adverse Event Report: BIOMET 3I CERTAIN® GOLD-TITE® HEXED SCREW; ABUTMENT SCREW

Catalog Number	IUNIHG
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned.
Event or Problem Description
It was reported that the abutment screw (iunihg) has loosened.Tooth location 31.
Additional Manufacturer Narrative
One gold tite hexed screw was retuned and inspected.A visual inspection of the product identified that the screw was worn from use at the body, and the drive feature is confirmed to be damaged.A device malfunction was confirmed.No lot number and was provided.Therefore, a dhr review and lot history review could not be performed.Appropriate documentation was reviewed for item usage.The condition of the device following manufacturing and shipping from the zimmer biomet site could not be verified without relevant dhr information or a physical specimen to review, however, there is no evidence that suggests the device did cause or contribute to the reported event and zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A root cause for the identified malfunction could not be determined.The screw loosening event could not be verified.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections are being reported: the reported screw loosening event could not be confirmed.No issues were identified during investigation that could have caused or contributed to the reported event.Product has been received by zimmer biomet.Product was misplaced in house.If investigation can be completed, a follow-up mdr will be submitted.No relevant infoation such as device photographs or x-rays were returned.As a result, a thorough investigation cannot be performed.A device history review (dhr) and complaint history review could not be performed as the item and lot number are unknown.Based on the available information and risk associated with the complaint, probable causes related to the reported event include customer error in screw torqueing, abutment assembly and prepping.It is stated by the customer that the patient has bruxism, which could contribute to the thread damage.The condition of the device following manufacturing and shipping from the zimmer biomet site could not be verified without relevant dhr information or a physical specimen to review, however, there is no evidence that suggests the device did cause or contribute to the reported event and zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.
Event or Problem Description
It was reported that the patient presented with a failed implant screw (iunihg) at tooth site #31.The implant screw was in tact.It was loose and the threads failed.

• Brand Name: CERTAIN® GOLD-TITE® HEXED SCREW
• Common Device Name: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7931079
• Report Number: 0001038806-2018-00849
• Device Sequence Number: 10168308
• Product Code: NHA
• Combination Product (Y/N): N
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2019

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 Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 02/20/2019; 03/14/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 02/21/2019; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1