LONESTAR
Report
- Report Number
- 2183449-2024-00023
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- September 15, 2024
- Report Date
- December 10, 2024
- Manufacturer
- ORTHOFIX US LLC
- Product Code
- LXH
- UDI-DI
- 18257200086092
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE IMPLANT INSERTER (PN: 83-9003, LN:227533-AC09) WAS RETURNED FOR INVESTIGATION. THE IMPLANT INSERTER SHOWS SIGNS OF WEAR INCLUDED SLIGHTLY FADED LASER MARKINGS AND SCRATCHES. IT CAN BE CONFIRMED THAT THE THREADED TIP BROKE OFF THE INSERTER. THE BROKEN THREADED TIP WAS NOT RETURNED FOR INVESTIGATION, BUT WAS SAFELY REMOVED DURING SURGERY, WITH NO PATIENT HARM REPORTED. PRE-CLINICAL TESTING (10112150) OF 83-9003 INSERTER INVOLVED IMPACTION AND REMOVAL AGAINST 58.7 LBS DISTRACTION FORCE FOR 507 CYCLES. THE OP-TECH MENTIONS "IF REPOSITIONING IS NEEDED, USE THE TAMP TO ADJUST THE INTERBODY SPACER POSITION". PER THE IFU, THE INSTRUMENT SHOULD NOT BE USED IF THERE IS ANY SIGN OF DAMAGE SUCH AS BINDING OR BENDING. AN ANALYSIS OF FAILURE SITE INDICATES THAT THE THREADED TIP WAS LIKELY SUBJECTED TO CUMULATIVE PERMANENT DEFORMATION (I.E. BENDING), PRIOR TO BREAKAGE. GIVEN THE NATURE OF THE INSTRUMENT'S DESIGN AND ITS INTERFACE WITH THE IMPLANT, CARE SHOULD BE TAKEN WHEN POSITIONING AND/OR POSITIONING WHILE IMPACTING, WITH RESPECT TO THE AMOUNT OF DISTRACTION FORCE VERSUS THE INPUT POSITIONING FORCE. ANY TOGGLE OR EXCESSIVE MOVEMENT OF THE INSERTER RELATIVE TO THE MOVEMENT OF THE IMPLANT SHOULD WARRANT AN INSPECTION FOR PERMANENT BENDING OF THE THREADED TIPS. THIS INSTRUMENT WAS MANUFACTURED IN MARCH 2023 AND THE COMPLAINT ORIGINATED IN NOVEMBER 2024, INDICATING IT WAS WITHIN THE EXPECTED 4-YEAR LIFESPAN. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF NCMR DATABASES DID NOT REVEAL ANY NONCONFORMANCES RELATED TO THIS INVESTIGATION.
PRODUCT HAS NOT RETURNED FOR INVESTIGATION.
IT WAS REPORTED THAT DURING A TWO LEVEL ACDF ON (B)(6)2024, WHILE INSERTING THE CAGE, THE TIP OF THE INSERTER BROKE INSIDE THE THREADS OF THE CAGE. IT WAS CONFIRMED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT THAT WAS INSIDE OF THE TRAY. IT WAS REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. SEVERAL ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO GOOD REULTS. THE DEVICE HAS NOT RETURNED FOR INVESTIGATION. WHEN THE DEVICE RETURNS AN INVESTIGATION WILL BE CONDUCTED ON THE DEVICE.
IT WAS REPORTED THAT DURING A TWO LEVEL ACDF ON (B)(6) 2024, WHILE INSERTING THE CAGE, THE TIP OF THE INSERTER BROKE INSIDE THE THREADS OF THE CAGE. IT WAS CONFIRMED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT THAT WAS INSIDE OF THE TRAY. IT WAS REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. SEVERAL ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO GOOD RESULTS. THE DEVICE HAS NOT RETURNED FOR INVESTIGATION. WHEN THE DEVICE RETURNS AN INVESTIGATION WILL BE CONDUCTED ON THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2314883 | LONESTAR | IMPLANT INSERTER | LXH | ORTHOFIX US LLC | 83-9003 | 227533-AC09 | 18257200086092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |