MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN GOLD-TITE HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that a fracture portion was found inside the implant, screw iunihg fractured.
Additional Manufacturer Narrative
Zimvie received one (1) iunihg, (certain gold-tite tm hexed screw) for evaluation.Visual evaluation was performed.The screw-like fractured fragment observed stuck to the implant is likely from a removal tool.Presence of the reported fracture screw fragment inside the implant could not be verified.Dhr review was completed for the subject lot number 1238373.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1238373 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz rev 22, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction could not be verified.He screw-like fractured fragment observed stuck to the implant is likely from a removal tool.Presence of the reported fracture screw fragment inside the implant could not be verified.The reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed, and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.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 "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23302410
• Report Number: 0001038806-2025-02447
• Device Sequence Number: 13250033
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)250728(10)1238373
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: Other
• Device Expiration Date: 07/28/2025
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1238373
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic