ZFX, GENTEK RETAINING SCREW, TSV/TM
Report
- Report Number
- 3008932779-2025-00035
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Report Date
- November 14, 2025
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZFX RECEIVED TWO (2) SCREW HEADS FROM SCREW ZFX GENTEK RETAINING SCREW, TSV/TRABECULAR METAL, THIS TYPE OF SCREW IS PART OF THE PACKAGE ZFX11-ZB-TSV-3547-NEL WHICH INCLUDESTHIS TI-SCREW, A POM SCREW AND THE TI-BASE. FROM THE TWO SCREW HEADS RECEIVED, ZFX CANNOT CONFIRM WHICH ONE CORRESPONDS TO THE SCREW PACKAGED WITH ZFX11-ZB-TSV-3547-NEL OR TO THE SCREW AS A FINAL PRODUCT ZFX09-ZB-TSV-RS. THE SCREWS ARE THE SAME DRAWING MATCH, SO IT CAN NOT BE ASSIGNED TO A CASE AND THE SELECTION WAS MADE ARBITRARILY. VISUAL INSPECTION: THE SCREW IS BROKEN UNDER THE SCREW HEAD. THE REST OF THE SCREW HAS NOT BEEN SENT TO ZFX. FRACTURE SITS FROM THE SCREW SHOWS SWING FRACTURE, CAUSED PROBABLY BY UNILATERAL BENDING , CAUSED BY UNILATERAL BENDING. THE SCREW HEAD IS IN USED CONDITION AND HAS SCRATCHES. THE CONTACT SURFACE ON THE UNDERSIDE OF THE SCREWHEAD IS IN USED CONDITION, NO ABNORMALITIES FOUND. FUNCTIONAL TEST: THE SCREW HEAD IS FUNKTIONALLY OK. DIMENTIONALLY IT WORKS, THE INNER HEX IS IN USABLE CONDITION. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2120031732 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE : SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS FRACTURE. THE EXACTLY ROOT CAUSE FROM FRACTURE CAN NOT BE DETERMINED WITH THIS INFORMATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR AS NO DEVIATION WERE FOUND THROUGH THE VISUAL AND FUNCTIONAL EVALUATION. THE SCREW WAS FRACTURED. THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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.
ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED A3: GENDER UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED B3: DATE OF EVENT UNKNOWN / NOT PROVIDED D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED D10. CONCOMITANT MEDICAL PRODUCTS ZFX11-ZB-TSV-3547-NEL, ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH, LOT 2120020317. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
THE DOCTOR REPORTS THAT THE DENTAL SCREWS FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301175 | ZFX, GENTEK RETAINING SCREW, TSV/TM | DENTAL SCREW | NHA | ZFX GMBH | 2120031732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DENTAL SCREW SEE H10 NARRATIVE |