LONESTAR
Report
- Report Number
- 2183449-2024-00025
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Report Date
- December 13, 2024
- Manufacturer
- ORTHOFIX US LLC
- Product Code
- LXH
- UDI-DI
- 18257200086092
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE IMPLANT INSERTER (PN: 83-9003 LN:214636-WB25) WAS RETURNED FOR INVESTIGATION. THE IMPLANT INSERTER SHOWS MINIMAL SIGNS OF WEAR. 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. 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.
THE IMPLANT INSERTER (PN: (B)(4), LN: 214636-WB25) WAS RETURNED FOR INVESTIGATION. THE IMPLANT INSERTER SHOWS MINIMAL SIGNS OF WEAR. 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 (B)(4) 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. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF NCMR DATABASES DID NOT REVEAL ANY NONCONFORMANCE'S RELATED TO THIS INVESTIGATION.
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. THE DISTRIBUTOR REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. NO FURTHER CASE DETAILS WERE PROVIDED.
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. THE DISTRIBUTOR REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. NEW INFORMATION RECEIVED 12/13/2024 THIS REPORT IS UPDATES THE NEW CASE INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415105 | LONESTAR | INPLANT INSERTER | LXH | ORTHOFIX US LLC | 83-9003 | 214636-WB25 | 18257200086092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |