GENTEK HEXALOBULAR SCREWDRIVER, 21 MM
Report
- Report Number
- 3008932779-2025-00029
- Event Type
- Malfunction
- Date Received
- August 19, 2025
- Date of Event
- July 22, 2025
- Report Date
- August 27, 2025
- Manufacturer
- ZFX GMBH
- Product Code
- NDP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
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 ZIMVIE RECEIVED ONE (1) ITEM ZFX02HLD21. VISUAL EVALUATION WAS PERFORMED. WE SEE A SCREWDRIVER WITH BROKEN TIP. THE SCREWDRIVER HAS DAMAGES AND SCRATCHES FROM USE.THE SCREWDRIVER TIP HAS BEEN STRENGTHENED BY OFTEN USE AND/OR HIGH TORQUE VALUES, THE BREAKAGE AREA SHOWS SIGNES OF TORSION AND A SUDDEN BREAKAGE TYPE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2412020709. 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 2412020709 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE RMF, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS SUDDEN BREAKAGE AFTER OVERTORQING OF THE SCREWDRIVER. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED.. 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.
THE WORKING PART OF THE DRIVER (HEXALOBULAR HEAD) FRACTURED WHILE UNSCREWING A HEXALOBULAR SCREW FROM A T-BASE. PROCEDURE NOT COMPLETED. NO IMPACT ON THE PATIENT'S HEALTH.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1866012 | GENTEK HEXALOBULAR SCREWDRIVER, 21 MM | DENTAL DRIVER | NDP | ZFX GMBH | 2412020709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |