MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE® HEXED RETAINING SCREW - 3MM; DENTAL SCREW

Model Number	GSH30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
It was reported that the hexed retaining screw fractured.They already ordered replacement screw.Tooth location not reported.
Additional Manufacturer Narrative
Gold-tite® hexed retaining screw - 3mm (gsh30) 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.Functional testing could not be performed since the products were not returned.Pre-existing condition, tooth location and placement duration were unknown due to limited information provided by customer.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1236724).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, 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 (1236724) for similar event using and no other complaints were 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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative h3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that mfr report numbers 0001038806-2021-01426 and 0001038806-2021-01426-1 were reported in error.Please disregard this submission.No further reports will be submitted for this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: GOLD-TITE® HEXED RETAINING SCREW - 3MM
• Common Device Name: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12263714
• Report Number: 0001038806-2021-01426
• Device Sequence Number: 6061442
• Product Code: NHA
• UDI-Device Identifier: 00844868003984
• UDI-Public: (01)00844868003984(17)250224(10)1236724
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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: Lay User/Patient
• Device Expiration Date: 02/24/2025
• Device Model Number: GSH30
• Device Catalogue Number: GSH30
• Device Lot Number: 1236724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 04/06/2022
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 12/09/2021; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose