GENTEK HEXALOBULAR SCREWDRIVER, 21 MM
Report
- Report Number
- 3008932779-2025-00022
- Event Type
- Malfunction
- Date Received
- July 7, 2025
- Date of Event
- January 10, 2025
- Report Date
- July 31, 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. E1: REPORTER EMAIL ADDRESS UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. ZIMVIE DID NOT RECEIVE ONE (1) ITEM NUMBER. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE RISK MANAGEMENT FILE (RMF). BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER 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. WITHOUT DEVICE RECEIPT, 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 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 CMP-(B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D9: DEVICE AVAILABILITY 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 DID RECEIVE ONE (1) ZFX02HLD21 ON PBG AND THEN WAS LOST IN TRANSIT. WE HAVE NO LOT NUMBER VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION (PICTURES) USING THE RISK MANAGEMENT FILE (RMF). THE HOLDER, SHOWED AT THE PICTURES, AND HIS LOT ARE NOT SUBJECT OF THE INVESTIGATION. THE SURFACE FROM SCREWDRIVER SHOWS RUST AT THE PICTURES. THE SURFACE SHOWS SMALL SCRATCHES AND DAMAGES, IT IS IN WELL USED CONDITION. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS SUDDEN BREAKAGE AFTER OVERTORQIUNG OF THE SCREWDRIVER. THE SCREWDRIVER SEEMS RUSTED, MAY THE CLEANING AGENT WAS TO AGRESSIVE OR THE PARTS WAS SPENT TOO MUCH TIME IN THE MOIST ENVIRONMENT. IT COULD HAVE BE DAMAGED THE SURFACE AND HAVE WEAKEND THE COMPONENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. WITHOUT DEVICE RECEIPT, 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.
IT WAS REPORTED THAT THE DRIVER TIP IS FRACTURED. PROCEDURE COMPLETED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2819562 | GENTEK HEXALOBULAR SCREWDRIVER, 21 MM | DENTAL DRIVER | NDP | ZFX GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |