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

Catalog Number IUNIHG

Device Problem Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Event date unknown/not provided.Device lot number is not provided/unknown.Device has not been received by manufacturer.

Event Description

It was reported that an abutment screw (iunihg) fractured inside an implant (ios4510).One fragment of the screw remains inside the implant and is planned to be retrieved.The implant is reported to be stable and the physician plans to replace abutment following screw retrieval.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: instructions for use for zimmer dental implant systems¿ 4894i rev 3-07/09.Zimmer dental abutments are seated with the 1.25mm standard hex tool, latchlock hex tool, or the spectra-cone seating tool.The use of a prosthetic torque wrench is recommended to ensure optimum torque when placing the abutment or abutment screw.When using the latchlock hex tool, operate at 25rpm or less with a maximum torque of 30ncm.Risks associated with the reported event are highlighted in the risk management files rm-002z6 rev 2 and rm-002b7 rev 4: excessive loading on abutment/implant assembly, leading to abutment and/or screw failure.Screw over-torqued into implant, causing abutment and/or screw failure.Incorrect assembly of the abutment and/or screw to the implant (i.E.Crossthreading, abutment not seated properly, improper torque application, used with incorrect implant), causing abutment and/or screw fracture and implant failure.Without the returned product, there is not enough evidence to form a conclusion on the reported event of abutment screw fracture.Therefore, the complaint is non-verifiable.A probable cause cannot be determined.

• Brand Name: CERTAIN® GOLD-TITE® HEXED SCREW
• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 7218003
• MDR Text Key: 98310101
• Report Number: 0001038806-2018-00059
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1