RETAINING 2.5MM HEX DRIVE R LONG
Report
- Report Number
- 0002023141-2023-00287
- Event Type
- Malfunction
- Date Received
- January 25, 2023
- Report Date
- January 27, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- NDP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D1: BRAND NAME . D4: CATALOG NUMBER. D4: LOT/SERIAL # . G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H4: DEVICE MANUFACTURER DATE . H10: ADDED MANUFACTURER NARRATIVE.
ONE (1) IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 8MM (TSVH8) & ONE (1) RETAINING 2.5MM HEX DRIVE R LONG (RHL2.5) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT; VERIFIED THE RHL2.5 WAS STUCK AND WOULD NOT RELEASE FROM THE IMPLANT. THE RHL2.5 HEX MEASURED 2.5MM. THE DRIVER IS FOR PLACEMENT ONLY VIA THE FMT. (MISUSE.) A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE. THE REPORTED IMPLANT WAS LOCATED ON TOOTH # 30 (UNIVERSAL) AND WAS USED, PLACED AND REMOVED ON THE SAME DAY. THE LENGTH OF THE DRIVER USAGE IS UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1252605 & 0301747). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1252605 & 0301747) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) OR PRODUCT (TSVH8 & RHL2.5). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICES MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. HOWEVER, ZIMVIE HAS FOUND THAT THE ISSUE RAISED AND INVESTIGATED THROUGH THIS COMPLAINT IS RELATED TO AN UNINTENDED USE OF THE DEVICE PER IFU 8874 REV 5. THE 2.5MMD HEX DRIVERS (GEMLOCK DELIVERY SYSTEM) SHOULD BE USED TO DELIVER ALL TAPERED SCREW-VENT IMPLANTS VIA THE FIXTURE MOUNT/TRANSFER.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. LOT/SERIAL # UNKNOWN / NOT PROVIDED. DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. EMAIL UNKNOWN / NOT PROVIDED. FIRST NAME UNKNOWN / NOT PROVIDED. LAST NAME UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT IMPLANT WAS PLACED AND WHEN THE HEX TOOL WAS TRYING TO BE REMOVED AFTER USE, IT COULD NOT COME OUT OF THE IMPLANT. WE HAD TO REMOVE THE IMPLANT AND REPLACE WITH A LARGER DIAMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1060286 | RETAINING 2.5MM HEX DRIVE R LONG | IMPLANT PLACEMENT TOOL | NDP | ZIMMER DENTAL | 0301747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |