TOOL HEX SST 1.25MM 17MM
Report
- Report Number
- 0002023141-2021-03532
- Event Type
- Malfunction
- Date Received
- December 8, 2021
- Date of Event
- October 19, 2021
- Report Date
- May 27, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- NDP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: D10: TSVMWB10, IMP,TSV,MCOL MG,4.7MM,10M: LOT# 1248185,H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4307. ONE (1) TOOL HEX SST 1.25MM 17MM (HX1.25) & ONE (1) IMP,TSV,MCOL MG,4.7MM,10M (TSVMWB10) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE FRACTURED DRIVER, AND A PIECE OF IT IS INSIDE THE MOUNT. LOT NUMBER (2021031280) FOR DRIVER IDENTIFIED DURING INSPECTION. BASED ON THE EVALUATION, DEVICE MALFUNCTION DID OCCUR FOR BOTH REPORTED DEVICES AS THE FRACTURED HX1.25 TIP WAS IDENTIFIED IN THE IMPLANT MOUNT. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE LIKELY WITHIN SPECIFICATION AND LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (2021031280 & 1248185). 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 (2021031280 & 1240261) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION, THE MOST LIKELY CAUSE FOR THESE EVENTS/FAILURES IS CUSTOMER/USER ERROR AND EXCESSIVE TORQUE PLACED ON TOOL DUE TO IMPROPER SURGICAL PROCEDURE. 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.
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. LOT NUMBER UNKNOWN / NOT PROVIDED. FAX NUMBER UNKNOWN / NOT PROVIDED. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE, THE DRIVER BROKE INSIDE THE TRANSFER ABUTMENT AND THE IMPLANT AT TOOTH LOCATION #19 HAD TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1856612 | TOOL HEX SST 1.25MM 17MM | DENTAL TOOL | NDP | ZIMMER DENTAL | 2021031280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | DENTAL IMPLANT |