PERLA TL NAV LOCKING SCREWDRIVER XTAB
Report
- Report Number
- 3007728266-2024-00004
- Event Type
- Malfunction
- Date Received
- May 2, 2024
- Date of Event
- April 3, 2024
- Report Date
- July 22, 2024
- Manufacturer
- SPINEART SA
- Product Code
- OLO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE 2 COMPLAINED INSTRUMENTS WERE RETURNED TO US, AND WE DID NOT DETECT ANY VISUAL ISSUE THE R&D DEPARTMENT CONDUCTED FUNCTIONAL TESTING WITH THE COMPLAINED INSTRUMENTS AND FOLLOWING TEST DEVICES: 2 XTAB CANNULATED FENESTRATED SCREWS: REF. MPF-PX 55 45-S, BATCH NUMBER: 7-7534 THESE SCREWS ARE CORRESPONDING TO THE BATCH NUMBER OF THE 2 SCREWS WHICH WERE IMPLANTED DURING THE PROCEDURE. 2 K-WIRE BLUNT STAINLESS STEEL: REF. MPF-IN 12 02-N, BATCH NUMBER: 7-2868. 1 STRAIGHT HANDLE RATCHET: HAN-SB RF ST-N, BATCH NUMBER: 5-3363. THE XTAB CANNULATED FENESTRATED SCREWS WAS ASSEMBLED WITH THE PERLA TL NAV LOCKING SCREWDRIVER XTAB. FINALLY, THE HANDLE WAS CONNECTED TO THE PERLA TL NAV LOCKING SCREWDRIVER XTAB. THE K-WIRE WAS PASSED THROUGH THE ASSEMBLED INSTRUMENTS, AND IT IS OBSERVED THAT THERE COULD BE A FRICTION. THIS IS MAINLY DEPENDENT ON THE TIGHTENING OF THE HANDLE. THE K-WIRE PASSES SMOOTHLY WHEN THE HANDLE IS NOT TOO HARD TIGHTENED, BUT THERE IS A BLOCKING EFFECT WHEN THE HANDLE IS TOO HARD TIGHTENED. HOWEVER, THE ASSEMBLED INSTRUMENTS WERE STILL FUNCTIONAL. AS A PREVENTIVE ACTION, THE DIMENSIONAL COAXIALITY TEST AT THE CONTROL STEP WILL BE IMPLEMENTED (DIS-00755). THE INSTRUMENTS OF THIS BATCH HAVE BEEN ON THE FIELD SINCE 2022 AND THIS IS THE FIRST COMPLAINT WE RECEIVED FOR THIS ISSUE. WE ALSO REVIEWED IF THIS ISSUE HAS BEEN OBSERVED FOR OTHER BATCHES, BUT IT IS THE FIRST COMPLAINT WE RECEIVED FOR THE PERLA TL NAV LOCKING SCREWDRIVER XTAB CONCERNING THIS DEFICIENCY. WE CAN CONCLUDE THAT THIS IS AN ISOLATED CASE.
WE ARE WAITING FOR THE INSTRUMENT RETURN TO INVESTIGATE.
ON 22.APR.2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER (B)(4), REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN INTRODUCING THE K-WIRE THROUGHOUT THE NAV SCREWDRIVER (NAV-IN 37 20-N) WITH THE CANNULATED SCREW IN PLACE, IT GOT STUCK. AFTER THE SURGERY, AND CHECKING THAT THE SHANK WAS CLEAN, THE SAME PROBLEM APPEARED WHEN TRYING TO GO THROUGH IT WITH THE SCREW IN PLACE BUT NOT WHEN DOING THE SAME ACTION WITHOUT THE SCREW. THE SURGERY WAS DELAYED FOR APPROXIMATELY 45 MINUTES AS THE DOCTOR INITIALLY ATTEMPTED TO RESOLVE THIS ISSUE. HOWEVER, AFTER BEING UNABLE TO ADVANCE THROUGH THE K-WIRE, HE DECIDED TO PERFORM A WIRE-FREE TECHNIQUE AND HE COMPLETED THE SURGERY. WE WERE INFORMED ON (B)(6) 2024 THAT THE PATIENT RECEIVED ADDITIONAL ANAESTHESIA.THE PATIENT IS FINE.
ON (B)(6) 2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER CPT-2943, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN INTRODUCING THE K-WIRE THROUGHOUT THE NAV SCREWDRIVER (NAV-IN 37 20-N) WITH THE CANNULATED SCREW IN PLACE, IT GOT STUCK. AFTER THE SURGERY, AND CHECKING THAT THE SHANK WAS CLEAN, THE SAME PROBLEM APPEARED WHEN TRYING TO GO THROUGH IT WITH THE SCREW IN PLACE BUT NOT WHEN DOING THE SAME ACTION WITHOUT THE SCREW. THE SURGERY WAS DELAYED FOR APPROXIMATELY 45 MINUTES AS THE DOCTOR INITIALLY ATTEMPTED TO RESOLVE THIS ISSUE. HOWEVER, AFTER BEING UNABLE TO ADVANCE THROUGH THE K-WIRE, HE DECIDED TO PERFORM A WIRE-FREE TECHNIQUE AND HE COMPLETED THE SURGERY. WE WERE INFORMED ON 24.APR.2024 THAT THE PATIENT RECEIVED ADDITIONAL ANAESTHESIA. THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857242 | PERLA TL NAV LOCKING SCREWDRIVER XTAB | PERLA TL NAV LOCKING SCREWDRIVER XTAB | OLO | SPINEART SA | NAV-IN 37 20-N | 6-8258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |