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

Catalog Number IUNIHG

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Date of event unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported that a broken screw was discovered when the patient came in the office with the crown in hand.Screw was removed and the implant is intact and threads seem to be fine.Screw was sucked in to the system upon removal.Screw lot number and abutment information can not be identified at this time by the doctor or lab.Tooth location not reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

One certain gold-tite hexed screw (iunihg) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files to address reported event.No allegation made to the implant.Functional testing could not be performed since the products were not returned.Pre-existing conditions, tooth location and duration of placement was unknown due to limited information provided by customer.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review could not be performed as the lot number associated with the reported devices were not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.(iunihg): a year-long complaint history review by item number (iunihg) was performed for similar category and no complaint about nonconforming products was identified.Based on the available information, device malfunction and the reported events could not be verified as the exact details of event were non-verifiable and the products were not returned.H3 other text: device not returned.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11316381
• MDR Text Key: 231642618
• Report Number: 0001038806-2021-00240
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR