BIOABSORBABLE INTERFERENCE SCREWS
Report
- Report Number
- 3004549189-2024-00001
- Event Type
- Malfunction
- Date Received
- March 14, 2024
- Date of Event
- February 26, 2024
- Report Date
- November 6, 2024
- Manufacturer
- S.B.M. SAS
- Product Code
- MAI
- PMA / PMN Number
- K122228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6) 2024 USE OF 2 SCREWS DURING THE PROCEDURE (1 IN THE TIBIA / 1 IN THE FEMUR): REF. (B)(4) LOT 221544 - COMPOSITCP60 INTERFERENCE SCREWS ROUND HEAD Ø9MM L25MM AND REF. (B)(4) LOT 232481 - COMPOSITCP30 INTERFERENCE SCREWS ROUND HEAD Ø8MM L25MM. ROOT CAUSE OF THE DELAY: "BROKEN SCREWS IN THE FEMUR AND TIBIA THAT HAD TO BE REMOVED" - "BROKEN SCREW LEFT IN THE TIBIA". ONLY THE 221544 BATCH WOULD BE AVAILABLE FOR EVALUATION. ACCORDING TO THE INCIDENT REPORT, THIS IS A REVIEW INTERVENTION. NO ADDITIONAL INFORMATION. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBERS - NO INCIDENT DURING MANUFACTURING. TO COMPLETE OUR INVESTIGATION, REQUEST ADDITIONAL INFORMATION ABOUT THE CIRCUMSTANCES OF THE INCIDENT AND THE CLINICAL CONSEQUENCES FOR THE PATIENT. REQUEST RETRIEVAL OF DEVICE.S FOR ANALYSIS.
(B)(6) 2024: USE OF 2 SCREWS DURING THE PROCEDURE (1 IN THE TIBIA / 1 IN THE FEMUR): REF. 905256 LOT 221544 - COMPOSITCP60 INTERFERENCE SCREWS ROUND HEAD Ø9MM L25MM AND REF. 110004609 LOT 232481 - COMPOSITCP30 INTERFERENCE SCREWS ROUND HEAD Ø8MM L25MM. ROOT CAUSE OF THE DELAY: "BROKEN SCREWS IN THE FEMUR AND TIBIA THAT HAD TO BE REMOVED" - "BROKEN SCREW LEFT IN THE TIBIA". ONLY THE 221544 BATCH WOULD BE AVAILABLE FOR EVALUATION. ACCORDING TO THE INCIDENT REPORT, THIS IS A REVIEW INTERVENTION. NO ADDITIONAL INFORMATION. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBERS - NO INCIDENT DURING MANUFACTURING. TO COMPLETE OUR INVESTIGATION, REQUEST ADDITIONAL INFORMATION ABOUT THE CIRCUMSTANCES OF THE INCIDENT AND THE CLINICAL CONSEQUENCES FOR THE PATIENT. REQUEST RETRIEVAL OF DEVICES FOR ANALYSIS. NOVEMBER 06, 2024: ADDITIONAL INFORMATION - ANALYSIS OF THE 2 SCREWS RETURNED. COMPOSITCP60 Ø9 L25 SEPARATE HEAD / LOT 221544: THE SCREW IS BROKEN INTO SEVERAL PIECES, ONLY 2 WERE RETURNED. LENGTH OF THE PIECE INCLUDING THE SCREW HEAD: MINIMUM 7,70MM / MAXIMUM 10,96MM. THE PIECE WITH THE TIP IS MISSING. THE FRACTURE OCCURRED AT THE FIRST AND LAST THIRD OF THE LENGTH. THE THREADS ARE FREE OF DAMAGE, HEAD SIDE, AND ON THE MIDDLE SHARD THE SCREWDRIVER RECESS IS UNDAMAGED ON THE RECOVERED PIECES OF SCREWS. CONTROL OF THE CAVITY WITH A Ø9MM SCREWDRIVER (LOT 130671) : IT DOES NOT COME TO REST AT THE BOTTOM OF THE SCREW'S CAVITY IN THE ABSENCE OF THE TIP. TISSUE RESIDUES ARE PRESENT AT THE FRACTURE LEVEL IN THE FIRST THIRD. THE TCP GRANULES ARE CLEARLY VISIBLE. THIS BATCH OF SCREWS DOES NOT PRESENT ANY MANUFACTURING ANOMALIES. EVERYTHING IS IN COMPLIANCE. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF LIGAFIX, THE IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF THE FAILURE. THE HIGH LEVEL OF MOLECULAR MASS OF THIS BATCH OF SCREWS ATTESTS TO THE VERY GOOD PROGRESS OF ITS MANUFACTURING. OBSERVATION OF THE SCREW REVEALS A COMBINED RUPTURE OF TWISTING AND PERFORATION AT THE BIRTH OF THE SCREWDRIVER RECESS. IN THE ABSENCE OF MANY ELEMENTS ON THE CIRCUMSTANCES OF THE SCREW'S BREAKAGE, THE HYPOTHESIS THAT COULD EXPLAIN THIS BREAKAGE IS AS FOLLOWS: DURING SCREWING, THE SCREW PRODUCED A DIVERGENT TRAJECTORY IN THE TUNNEL, CAUSING SIGNIFICANT STRESSES IN BENDING AND TORSION UP TO THE CORE OF THE SCREW, PARTICULARLY WHEN PASSING THE CORTICAL WALL. THESE CONSTRAINTS CAUSED A DEFORMATION OF THE SCREWDRIVER RECESS, WHICH IS ALMOST ZERO AT THE END OF THE SCREWDRIVER RECESS AND MAXIMUM AT THE LEVEL OF THE SCREW HEAD. THE DEFORMATION OF THE SCREWDRIVER IS THEN GREATER THAN THE ELASTIC LIMIT OF THE DUOSORB, CAUSING THE SCREW TO BREAK. COMPOSITCP60 Ø9 L25 DEFORMED SCREW TIP / LOT 221544: THE SCREW HAS A SIGNIFICANT DEFORMATION OF THE TIP OF THE SCREW AT THE LEVEL OF THE GUIDE PIN PASSAGE HOLE. THE DAMAGED SCREW MEASURES 24.7MM. THE FRACTURE ZONE IS 0.5MM. THE SCREW BROKE IN THE GUIDE PIN GUIDE ZONE. THE REST OF THE SCREW IS FREE OF ANY DAMAGE. OUTSIDE DIAMETER: 8.99MM. THE IMPRINT STARTS 0.05MM BELOW THE HEAD: CONTROL L GUIDE PIN ON SCREWS REJECTED AT THE START OF MANUFACTURING: 3MM: THE POSITIONING OF THE PIN DURING THE PREPARATION OF THE INJECTION MOLD IS IN COMPLIANCE WITH OUR MOP-MT-033 OPERATING PROCEDURE. CONTROL OF CAVITY WITH Ø9MM SCREWDRIVER (LOT 130671): ALL CLEAR, THE SCREWDRIVER EASILY PENETRATES THE IMPRINT AND STOPS AT THE BOTTOM OF THE IMPRINT. VERY GOOD VISIBILITY OF THE TCP GRANULES. THIS MANUFACTURING BATCH DOES NOT CONTAIN ANY MANUFACTURING ANOMALIES. EVERYTHING IS IN COMPLIANCE. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF SCREWS, ITS IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF ITS FAILURE. THE HIGH LEVEL OF MOLECULAR MASS OF THIS BATCH OF SCREWS ATTESTS TO THE VERY GOOD PROGRESS OF ITS MANUFACTURING. WE HAVE VERY LITTLE INFORMATION TO EXPLAIN WITH CERTAINTY WHY THE SURGEON WAS UNABLE TO INTRODUCE THIS SCREW, BUT THE SIGNIFICANT DEFORMATION OF THE TIP OF THE SCREW AT THE LEVEL OF THE GUIDE PIN PASSAGE HOLE COULD NOT HAVE BEEN CAUSED THAN BY THE GUIDE PIN. HYPOTHESIS : WE CONCLUDE THAT THE DAMAGE TO THE TIP WAS CAUSED BY A DIVERGENT TRAJECTORY OF THE SCREW RELATIVE TO THE TUNNEL. BY TAKING A DIVERGENT TRAJECTORY TO THE TUNNEL, THE SCREW BENT THE PIN, RESULTING IN THE INABILITY OF THE SCREW TO PROGRESS. CONTINUING SCREWING GENERATED MIGRATION OF MATERIAL AT THE TIP, DUE TO THE HEATING CAUSED BY THE CONTACT OF THE TIP OF THE SCREW WITH THE BENT GUIDE PIN. COMPOSITCP30 Ø8 L25 / LOT 232481 : BROKEN SCREW, NOT EXPLANTED - NO PHOTOS AVAILABLE. THIS MANUFACTURING BATCH DOES NOT CONTAIN ANY MANUFACTURING ANOMALIES. EVERYTHING IS IN COMPLIANCE. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF SCREWS, ITS IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF ITS FAILURE. THE HIGH LEVEL OF MOLECULAR MASS OF THIS BATCH OF SCREWS ATTESTS TO THE VERY GOOD PROGRESS OF ITS MANUFACTURING. HYPOTHESIS : A REMNANT OF THE PREVIOUSLY INSERTED SCREW MAY HAVE DEFLECTED THE TRAJECTORY OF THE Ø8 SCREW DURING ITS INSERTION. THE SURGEON IS FAMILIAR WITH THE DEVICE - PRODUCT QUALITY IS NOT IN QUESTION - THE ROOT CAUSE IS NOT CLEARLY ESTABLISHED - NO ACTION IMPLEMENTED.
(B)(4). INCIDENT OCCURED IN FRANCE: EVENT DESCRIPTION COMMUNICATED. (B)(4): "LIGAMENTOPLASTY WITH PATELLAR TENDON. SCREW PLACEMENT WITH NITINOL GUIDE AND TAPPING. THE SCREWS BROKE. EXTENSION OF THE PROCEDURE BY MORE THAN 30 MINUTES".
(B)(4). INCIDENT OCCURED IN FRANCE: EVENT DESCRIPTION COMMUNICATED. (B)(4): "LIGAMENTOPLASTY WITH PATELLAR TENDON. SCREW PLACEMENT WITH NITINOL GUIDE AND TAPPING. THE SCREWS BROKE. EXTENSION OF THE PROCEDURE BY MORE THAN 30 MINUTES".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2077699 | BIOABSORBABLE INTERFERENCE SCREWS | COMPOSITCP60 RESORBABLE INTERFERENCE SCREW - ROUND HEAD Ø9MM L25MM | MAI | S.B.M. SAS | 221544 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | Other |