TITANIUM HEXED UNISCREW
Report
- Report Number
- 0001038806-2020-01013
- Event Type
- Malfunction
- Date Received
- July 20, 2020
- Report Date
- May 14, 2021
- Manufacturer
- BIOMET 3I
- Product Code
- NHA
- PMA / PMN Number
- K072642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: LOT NUMBER , UDI NUMBER AND EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H4: DEVICE MANUFACTURE DATE.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: EXPIRATION DATE D4: UNIQUE IDENTIFIER (UDI) NUMBER 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 H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ONE (1) TITANIUM HEXED UNISCREW (UNIHT) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE SCREW FRACTURE AT THE THREADS REGION. SIGNS OF USE WERE SEEN. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230342). 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 WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230342) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D1: BRAND NAME. D2: DEVICE PRODUCT CODE. D4: ADDITIONAL DEVICE INFORMATION. D10: DEVICE AVAILABILITY. G4: DATE RECEIVED BY MANUFACTURER . G5: PREMARKET IDENTIFICATION PMA/510(K) NUMBER. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES. H10: ADDITIONAL NARRATIVE.
ZIMMERBIOMET COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. ONE (1) TITANIUM HEXED UNISCREW (UNIHT) WAS NOT RETURNED TO PBG 3I FOR INVESTIGATION. HOWEVER, A PICTURE ATTACHED TO THE COMPLAINT IDENTIFIED THE SCREW FRACTURED AT THE THREADED REGION. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 26 (FDI) AND WAS USED FOR SIX (6) MONTHS. ONE PICTURE WAS PROVIDED, IT CAN BE SEEN THE SCREW IS FRACTURED. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE UNIHT DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON- CONFORMANCES/CAPA/HHE /D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (SCREW FRACTURE) OR DEVICE (UNIHT). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT SCREW FRACTURED. DOCTOR WAS ABLE TO REMOVE ALL OF IT AND PLACE A REPLACEMENT. TOOTH SITE 26.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
ZIMMER BIOMET (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF THE EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. DEVICE PRODUCT CODE UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. SINCE THE LOT NUMBER AND DEVICE WILL NOT BE RETURNED, IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATED THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WOULD BE SUBMITTED. PRODUCT NOT RETURNED.
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758088 | TITANIUM HEXED UNISCREW | DENTAL SCREW | NHA | BIOMET 3I | 1230342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |