BONE SCREW Ø6,5 H.25MM
Report
- Report Number
- 3008021110-2022-00003
- Event Type
- Malfunction
- Date Received
- January 25, 2022
- Date of Event
- January 20, 2022
- Report Date
- July 13, 2022
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LPH
- PMA / PMN Number
- K172456
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE DHR OF THE INVOLVED LOT #2121633, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.
CHECKING THE DHR OF THE INVOLVED LOT #2121633, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. LIMACORPORATE REQUESTED THE BROKEN SCREW'S HEAD TO THE COMPLAINT SOURCE, HOWEVER IT WAS NOT AVAILABLE TO BE RETURNED. ANALYSIS ON SCREWS BELONGING TO THE SAME LOT # ARE CURRENTLY ONGOING. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2121633 - STER. 2100326, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) OUT OF (B)(4) BONE SCREWS WITH LOT #2121633 - STER. 2100326 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. IN ADDITION, THE MANUFACTURING CHARTS OF THE TAP DRILL FOR BONE SCREW 6.5 MM (PRODUCT CODE 9013.75.486, LOT #19AG0RV) WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 10 INSTRUMENTS MANUFACTURED WITH THE SAME LOT #. X-RAYS ANALYSIS: LIMACORPORATE ASKED FOR POST-OPERATIVE X-RAYS OF THE SHOULDER SURGERY, HOWEVER THEY WERE NOT AVAILABLE FOR EVALUATION. EXPLANTS ANALYSIS: LIMACORPORATE REQUESTED THE BROKEN SCREW'S HEAD TO THE COMPLAINT SOURCE, HOWEVER IT WAS NOT AVAILABLE TO BE RETURNED. IT WAS REPORTED THAT THE SCREW'S HEAD WAS SENT OUT TO THE BIOENGINEERING DEPT. OF THE HOSPITAL FOR ANALYSIS. A COPY OF THE ANALYSIS REPORT WAS REQUESTED BY LIMACORPORATE, YET IT WAS NOT AVAILABLE. IT WAS REPORTED BY THE COMPLAINT SOURCE THAT NO FAULT WAS FOUND WITH THE SCREW BY THE ANALYSIS. TESTS PERFORMED: TO FURTHER INVESTIGATE THE REPORTED INCIDENT, LIMACORPORATE DECIDED TO PERFORM AN ANALYSIS ON SCREWS BELONGING TO THE LOT # INVOLVED IN THIS COMPLAINT, AND ON OTHER LOT #S OF THE SAME PRODUCT CODE. SPECIFICALLY, THE FOLLOWING INVESTIGATIONS WERE PERFORMED: DIMENSIONAL ANALYSIS TO CONFIRM THE ABSENCE OF DIMENSIONAL ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE; ANALYSIS ON THE TORSIONAL PROPERTIES OF THE SCREWS ACCORDING TO ASTM F543-17 - STANDARD SPECIFICATION AND TEST METHODS FOR METALLIC MEDICAL BONE SCREWS. ELEVEN SCREWS WERE TESTED: THEY BELONGED TO PRODUCT CODE 8420.15.020 (25MM LENGTH) AND WERE AVAILABLE IN INTERNAL WAREHOUSES. OF THOSE, SIX BELONGED TO THE LOT NUMBER INVOLVED IN THIS COMPLAINT (# B)(4). THE RELEVANT DIMENSIONS OF ALL ABOVE MENTIONED SCREWS WERE WITHIN THE EXPECTED TOLERANCES, NO DEVIATION WAS DETECTED. IN ADDITION TO THE DIMENSIONAL CHECK, LIMACORPORATE PERFORMED AN ANALYSIS ON THE TORSIONAL PROPERTIES OF THE SCREWS ACCORDING TO ASTM F543-17 - STANDARD SPECIFICATION AND TEST METHODS FOR METALLIC MEDICAL BONE SCREWS. THE ANALYSIS WAS OUTSOURCED TO AN EXTERNAL LABORATORY. ALL THE BONE SCREWS WERE FOUND TO BE COMPLIANT TO THE MINIMUM ACCEPTABLE VALUES REPORTED ON ASTM F543-17, THEREFORE NO DEFORMATION NOR BREAKAGE APPEARED ON THE TESTED SCREWS. IN DETAILS, THE BONE SCREWS RESISTED A TORQUE LOADING OF AT LEAST 6.2 NM WITHOUT DEFORMATION OR BREAKAGE. THE TORSIONAL ANALYSIS OF THE SCREWS WAS STOPPED AT THE MINIMAL REQUIREMENTS ACCORDING TO ASTM F543-17 AS TESTING UNTIL BREAKAGE COULD NOT HAVE BEEN COMPLETED DUE TO LIMITS OF THE SCREWDRIVERS (BREAKAGE/DEFORMATION). CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #2121633 - STER. 2100326; NO DIMENSIONAL ANOMALY WAS DETECTED ON THE TESTED SCREWS, INCLUDING 6 SCREWS WITH LOT #2121633; IT WAS REPORTED THAT THE ANALYSIS PERFORMED BY THE HOSPITAL'S BIOENGINEERING DEPARTMENT FOUND NO ADVERSE FEATURES ON THE BROKEN SCREW'S HEAD ANALYZED (HOWEVER NO FURTHER DETAILS ARE AVAILABLE ON THE TEST PERFORMED); THE TORSIONAL PROPERTIES OF THE BONE SCREWS WERE TESTED, AND THE RESULTS CONFIRMED THE COMPLIANCE TO THE ASTM F543-17; WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE REPORTED BREAKAGE, HOWEVER WE MIGHT SPECULATE THAT THE BREAKAGE OF THE SCREW'S HEAD WAS DUE TO THE INCORRECT APPLICATION OF LOAD TO THE SCREW ITSELF BY THE FINAL USER. IN DETAILS, IT IS POSSIBLE THAT A MISALIGNMENT OF THE SCREWDRIVER LED TO AN INCORRECT TRANSMISSION OF LOADS TO THE SCREW'S HEAD. THE HEAD OF THE SCREW GOT THEREFORE UNPROPERLY STRESSED BY A NON-AXIAL APPLICATION OF THE TORQUE, ULTIMATELY CAUSING ITS BREAKAGE. ACCORDING TO THE SURGICAL TECHNIQUE, AFTER HOLES PREPARATION AND BEFORE SCREWS INTRODUCTION, IT IS POSSIBLE TO MAKE USE OF THE TAP DRILL FOR BONE SCREW 6.5 MM (PRODUCT CODE 9013.75.486) TO ENLARGE THE SCREW'S HOLE. IT WAS REPORTED BY THE COMPLAINT SOURCE THAT IT WAS STILL DIFFICULT WINDING THE SCREW IN EVEN AFTER USING THE TAP DRILL. YET, CONSIDERING THAT NO ANOMALY WAS FOUND ON THE MANUFACTURING CHARTS OF THE TAP DRILL FOR BONE SCREW 6.5 MM (PRODUCT CODE 9013.75.486, LOT #19AG0RV), WE DO NOT BELIEVE THAT THE ISSUE MIGHT HAVE BEEN RELATED TO ANY EVENTUAL IRREGULARITY ON HOLES PREPARATION CAUSED BY THE INSTRUMENT. IN CONCLUSION, WE CLASSIFY THE EVENT AS NOT PRODUCT RELATED BASED ON THE ANALYSIS PERFORMED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, WE CAN ESTIMATE THE INTRA-OPERATIVE BREAKAGE OF BONE SCREWS - BELONGING TO THE FAMILY CODES 8420.15.XXX - TO BE 0,001%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.
DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2022, THE LARGE METAL BACK GLENOID AND THE SUPERIOR SCREW FOR ITS FIXATION WERE IMPLANTED SUCCESSFULLY, WHILE THE INFERIOR SCREW WAS BEING PLACED IN, THE HEAD OF THE BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2121633, (B)(4)) BROKE WHEN THE SCREW WAS A FEW MILLIMETERS FROM BEING FULLY IN. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED IN WINDING THE SCREW IN. ACCORDING TO THE COMPLAINT SOURCE, BONE WAS HARD. AS IT WAS NOT POSSIBLE TO REMOVE THE SCREW SAFELY, IT WAS REPORTED THAT A PUNCH WAS USED TO FULLY SEAT THE REST OF THE SCREW IN. SURGERY WAS PROLONGED OF 20 MINUTES. IT WAS REPORTED THAT GLENOID FIXATION WAS ACHIEVED AND THE ANATOMICAL TSR WAS SUCCESSFULLY COMPLETED. EVENT HAPPENED IN (B)(6).
DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2022, THE LARGE METAL BACK GLENOID AND THE SUPERIOR SCREW FOR ITS FIXATION WERE IMPLANTED SUCCESSFULLY, WHILE THE INFERIOR SCREW WAS BEING PLACED IN, THE HEAD OF THE BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2121633 - STER. 2100326) BROKE WHEN THE SCREW WAS A FEW MILLIMETERS FROM BEING FULLY IN. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED IN WINDING THE SCREW IN. ACCORDING TO THE COMPLAINT SOURCE, BONE WAS HARD. AS IT WAS NOT POSSIBLE TO REMOVE THE SCREW SAFELY, IT WAS REPORTED THAT A PUNCH WAS USED TO FULLY SEAT THE REST OF THE SCREW IN. SURGERY WAS PROLONGED OF 20 MINUTES. IT WAS REPORTED THAT GLENOID FIXATION WAS ACHIEVED AND THE ANATOMICAL TSR WAS SUCCESSFULLY COMPLETED. EVENT HAPPENED IN AUSTRALIA.
DURING A SHOULDER SURGERY PERFORMED ON (B)(6) 2022, THE LARGE METAL BACK GLENOID AND THE SUPERIOR SCREW FOR ITS FIXATION WERE IMPLANTED SUCCESSFULLY. ACCORDING TO THE COMPLAINT SOURCE, PRIOR TO SCREWING IN THE BOTTOM SCREW, THE TAP DRILL FOR BONE SCREW 6.5 MM (PRODUCT CODE 9013.75.486, LOT #19AG0RV) WAS USED. IT WAS REPORTED THAT WHEN SCREWING THE BOTTOM SCREW, IT WAS STILL DIFFICULT WINDING IT IN. WHEN THE SCREW WAS A FEW MILLIMETERS FROM BEING FULLY IN, THE HEAD OF THE BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2121633 - STER. 2100326) BROKE. AS IT WAS NOT POSSIBLE TO REMOVE THE SCREW SAFELY, IT WAS REPORTED THAT A PUNCH WAS USED TO FULLY SEAT THE REST OF THE SCREW IN. IN WAS REPORTED THAT ANY METAL SHARDS WERE REMOVED, INCLUDING THE BROKEN SCREW HEAD. ACCORDING TO THE COMPLAINT SOURCE, BONE WAS HARD. SURGERY WAS PROLONGED OF 20 MINUTES DUE TO THIS ISSUE. IT WAS REPORTED THAT GLENOID FIXATION WAS ACHIEVED AND THE ANATOMICAL TSR WAS SUCCESSFULLY COMPLETED, CORRECTLY INSERTING THE LINER AS THE SCREW WAS INSERTED ENOUGH TO ALLOW THE LINER TO SEAT. EVENT HAPPENED IN AUSTRALIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1492074 | BONE SCREW Ø6,5 H.25MM | BONE SCREWS DIA. 6.5 X H. 25 MM | LPH | LIMACORPORATE S.P.A. | 8420.15.020 | 2121633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |