DENTAL TOOL
Report
- Report Number
- 0002023141-2024-00854
- Event Type
- Malfunction
- Date Received
- March 20, 2024
- Report Date
- August 7, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- NDP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER CMP-(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 H10: ADDITIONAL NARRATIVE IT WAS REPORTED THAT THE PRODUCT WAS DROPPED IN THE PATIENT'S MOUTH WHILE TRANSPORTING IT TO THE PATIENT. ASSISTANT STATED DOCTOR USED SAME WRENCH AND NEW IMPLANT TO COMPLETE PROCEDURE BUT NOT SURE WHAT WRENCH ITEM NUMBER IS. ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN PLACEMENT WRENCH FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN PLACEMENT WRENCH IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE - ZIMMER INSTRUMENT KIT SYSTEM, ZIMMER DENTAL SINGLE PATIENT DRILLS, DRIVA DRILLS, AND TOOLS, IFU 8874 REV. 6 - 10/22. INFORMATION IDENTIFIED: INDICATIONS, WARNINGS AND PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT REUSABLE SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE AND WEAR AND SHOULD BE INSPECTED AND CLEANED BEFORE EACH USE. THE NUMBER OF USES PER DRILL WILL VARY AND DEPENDS ON A VARIETY OF FACTORS INCLUDING BONE DENSITY ENCOUNTERED, PROPER HANDLING AND CLEANING. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-002W1 REV. 8, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS CUSTOMER ERROR (IMPROPER TECHNIQUES USED DURING PLACEMENT.) THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. 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 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.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D10. TSVT4B10, IMP,TSV,4.1,10,MTX,MG / 1271763. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IT WAS REPORTED THAT THE PRODUCT WAS DROPPED IN THE PATIENT'S MOUTH WHILE TRANSPORTING IT TO THE PATIENT. ASSISTANT STATED DOCTOR USED SAME WRENCH AND NEW IMPLANT TO COMPLETE PROCEDURE BUT NOT SURE WHAT WRENCH ITEM NUMBER IS. ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN PLACEMENT WRENCH FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN PLACEMENT WRENCH IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE - ZIMMER INSTRUMENT KIT SYSTEM, ZIMMER DENTAL SINGLE PATIENT DRILLS, DRIVA DRILLS, AND TOOLS, IFU 8874 REV. 6 - 10/22. INFORMATION IDENTIFIED: INDICATIONS, WARNINGS AND PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT REUSABLE SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE AND WEAR AND SHOULD BE INSPECTED AND CLEANED BEFORE EACH USE. THE NUMBER OF USES PER DRILL WILL VARY AND DEPENDS ON A VARIETY OF FACTORS INCLUDING BONE DENSITY ENCOUNTERED, PROPER HANDLING AND CLEANING. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-002W1 REV. 8, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS CUSTOMER ERROR (IMPROPER TECHNIQUES USED DURING PLACEMENT.) THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. 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 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.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THE PRODUCT WAS DROPPED IN THE PATIENT'S MOUTH WHILE TRANSPORTING TO THE PATIENT. ASSISTANT STATED DOCTOR USED SAME WRENCH AND NEW IMPLANT TO COMPLETE PROCEDURE BUT NOT SURE WHAT WRENCH ITEM NUMBER IT IS.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1700741 | DENTAL TOOL | NDP | ZIMMER DENTAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | DENTAL IMPLANT TSVT4B10. |