RESORBABLE INTERFERENCE SCREW
Report
- Report Number
- 3004549189-2025-00006
- Event Type
- Malfunction
- Date Received
- April 7, 2025
- Date of Event
- March 1, 2025
- Report Date
- July 9, 2025
- Manufacturer
- S.B.M. SAS
- Product Code
- MAI
- PMA / PMN Number
- K122228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON (B)(6) 2025 NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN - HOWEVER, THE PATIENT RETAINED A PIECE OF SCREW THAT WAS SUSCEPTIBLE TO MIGRATION. USE ANOTHER SCREW TO COMPLETE THE SURGERY. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - VERIFICATION OF MANUFACTURING DATA: 207 SCREWS PACKAGED - NO INCIDENTS DURING MANUFACTURE - NO REJECTS. THE BATCH COMPLIES WITH EXPECTED SPECIFICATIONS. ADDITIONAL INFORMATION REQUESTED / RESPONSES RECEIVED ON MARCH 07, 2025 : RE-EVALUATION OF THE REPORTABILITY. HOW DID THE DEVICE FRACTURE? WHAT STEPS WERE BEING PERFORMED AT THE TIME OF PRODUCT FAILURE? WHILE INSERTING THE TCP SCREW IN THE TUNNEL. DID THE PATIENT RETAIN PIECES OF BROKEN SCREW? YES. IF YES, CAN PIECES MIGRATE? YES. COULD YOU CONFIRM THAT THE EVENT CAUSED A DELAY OF 10MN AND NOT MORE THAN 30MN? 10MN. WHAT WAS THE DIAMETER OF THE TUNNEL? 9MM. HAS A PRIOR TAPPING OF THE TUNNEL BEEN CARRIED OUT? NO. WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? NO IDEA. WHAT WAS USED TO COMPLETE THE PROCEDURE (LOT NUMBER)? 905261 COMPOSI TCP INTERFERENCE SCREW 10X30MM LOT 240146. IS THE SURGEON FAMILIAR WITH THIS MEDICAL DEVICE? YES. WAS THIS HIS 1ST USE? BETWEEN 2 AND 10 POSES? OR MORE THAN 10 POSES? 2 POSES. DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? NO REQUEST TO RECOVER THE SCREW FOR EXPERTISE IF AVAILABLE. ____________________________________________________
(B)(6) 2025. NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN - HOWEVER, THE PATIENT RETAINED A PIECE OF SCREW THAT WAS SUSCEPTIBLE TO MIGRATION. USE ANOTHER SCREW TO COMPLETE THE SURGERY. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - VERIFICATION OF MANUFACTURING DATA: 207 SCREWS PACKAGED - NO INCIDENTS DURING MANUFACTURE - NO REJECTS. THE BATCH COMPLIES WITH EXPECTED SPECIFICATIONS. ADDITIONAL INFORMATION REQUESTED / RESPONSES RECEIVED ON MARCH 07, 2025 : RE-EVALUATION OF THE REPORTABILITY. HOW DID THE DEVICE FRACTURE? WHAT STEPS WERE BEING PERFORMED AT THE TIME OF PRODUCT FAILURE? => WHILE INSERTING THE TCP SCREW IN THE TUNNEL. DID THE PATIENT RETAIN PIECES OF BROKEN SCREW? YES IF YES, CAN PIECES MIGRATE? YES. COULD YOU CONFIRM THAT THE EVENT CAUSED A DELAY OF 10MN AND NOT MORE THAN 30MN? => 10MN WHAT WAS THE DIAMETER OF THE TUNNEL? 9MM. HAS A PRIOR TAPPING OF THE TUNNEL BEEN CARRIED OUT? NO. WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? NO IDEA. WHAT WAS USED TO COMPLETE THE PROCEDURE (LOT NUMBER)? 905261 COMPOSI TCP INTERFERENCE SCREW 10X30MM LOT 240146. IS THE SURGEON FAMILIAR WITH THIS MEDICAL DEVICE? YES. WAS THIS HIS 1ST USE? BETWEEN 2 AND 10 POSES? OR MORE THAN 10 POSES? 2 POSES. DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? NO. REQUEST TO RECOVER THE SCREW FOR EXPERTISE IF AVAILABLE. JULY 09, 2025. FOLLOW UP1 / RESULT OF THE EXPERTISE. BATCH 230593 COMPLIES WITH PRODUCTION SPECIFICATIONS. THE SCREW HAS A FRACTURED TIP AND DAMAGED THREADS AT THE ENTRY CONE. THE LATTER LIE BOTH FORWARD AND BACKWARD. THE INITIAL LENGTH OF THE SCREW WAS 30,2MM, HERE IT MEASURES 27,8MM THE FIRST THREE MILLIMETERS OF THE SCREW WERE CUT DURING THE SCREWING ATTEMPT. THE SCREW WAS DAMAGED ON 12,7MM. SCREW DIAMETER: 10,1MM - THE MAXIMUM DIAMETER OF THE DAMAGED AREA IS 8,5MM. THICKNESS OF THE SCREW TIP MEASURED ON A SAMPLE TAKEN DURING MANUFACTURING: 2,9MM COMPLIANT. THE RECESS BEGINS 0,2MM BELOW THE HEAD : CONTROL OF THE GUIDE LENGTH OF THE PIN ON SCREWS REJECTED AT THE START OF MANUFACTURING: 3MM. THE POSITIONING OF THE PIN DURING PREPARATION OF THE INJECTION MOLD COMPLIES WITH THE OPERATING MODE SBM MOP-MT-033. CHECKING THE RECESS WITH A Ø9/10/11 SCREWDRIVER (LOT 203204): ALL CLEAR, THE SCREWDRIVER EASILY ENTERS THE SCREW RECESS. GOOD VISIBILITY OF TCP GRANULES. OBSERVATION OF THE SCREW REVEALS A FRACTURE OF THE SCREW AT THE TIP (RECESS JUNCTION / GUIDE PIN PASSAGE HOLE) TO WHICH IS ADDED DAMAGE TO THE THREADS PRESENT ON THE ENTRY CONE. THEY LIE FORWARD AND BACKWARD. BREAKAGE OF THE TIP IS THE RESULT OF COMBINED SCREWING AND COMPRESSION FORCES EXERTED ON THE TIP OF THE SCREW DUE TO DIFFICULTIES ENCOUNTERED BY THE SURGEON IN INTRODUCING THE SCREW INTO THE TUNNEL. THE HYPOTHESES THAT COULD EXPLAIN THIS BREAKAGE IS AS FOLLOWS: 1. 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. FAILURE TO PRE-TAP THE TUNNEL USING THE APPROPRIATELY SIZED TAP INCREASES THE RISK OF THE SCREW BREAKING WHEN INSERTING IT INTO THE TUNNEL. 2. A TUNNEL DIAMETER SMALLER THAN THE SCREW DIAMETER GENERATED HIGH FRICTION FORCES OVER THE ENTIRE SURFACE OF THE SCREW WHEN PASSING THE CORTICAL WALL. ALL OF THESE CONSTRAINTS CAUSED A DEFORMATION OF THE SCREWDRIVER CAVITY: THE DEFORMATION BEING ALMOST ZERO AT THE END OF THE SCREWDRIVER CAVITY 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. HERE, THE TUNNEL HAS A DIAMETER OF 9 MM FOR A 10 MM DIAMETER SCREW, AND THE ENTRANCE HAS NOT BEEN TAPPED: NON-COMPLIANCE WITH SURGICAL TECHNIQUE. THE RESULT OF THE APPRAISAL IS FORWARDED TO OUR DISTRIBUTOR. NO ACTION IMPLEMENTED. THIS FILE IS CLOSED. JULY 09, 2025. FOLLOW UP2 / ADDITIONAL INFORMATION. A MEDWATCH FORM WAS SENT TO FDA BY THE DISTRIBUTOR CONCERNING THIS INCIDENT (B)(4) / ZIMMER BIOMET)). REPORT ID: (B)(6).
(B)(6) 2025. NO CLINICAL CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY OVER THAN 30MN - HOWEVER, THE PATIENT RETAINED A PIECE OF SCREW THAT WAS SUSCEPTIBLE TO MIGRATION. USE ANOTHER SCREW TO COMPLETE THE SURGERY. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - VERIFICATION OF MANUFACTURING DATA: 207 SCREWS PACKAGED - NO INCIDENTS DURING MANUFACTURE - NO REJECTS. THE BATCH COMPLIES WITH EXPECTED SPECIFICATIONS. ADDITIONAL INFORMATION REQUESTED / RESPONSES RECEIVED ON MARCH 07, 2025 : RE-EVALUATION OF THE REPORTABILITY. HOW DID THE DEVICE FRACTURE? WHAT STEPS WERE BEING PERFORMED AT THE TIME OF PRODUCT FAILURE? WHILE INSERTING THE TCP SCREW IN THE TUNNEL. DID THE PATIENT RETAIN PIECES OF BROKEN SCREW? YES. IF YES, CAN PIECES MIGRATE? YES. COULD YOU CONFIRM THAT THE EVENT CAUSED A DELAY OF 10MN AND NOT MORE THAN 30MN? 10MN. WHAT WAS THE DIAMETER OF THE TUNNEL? 9MM. HAS A PRIOR TAPPING OF THE TUNNEL BEEN CARRIED OUT? NO. WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? NO IDEA. WHAT WAS USED TO COMPLETE THE PROCEDURE (LOT NUMBER)? 905261 COMPOSI TCP INTERFERENCE SCREW 10X30MM LOT 240146. IS THE SURGEON FAMILIAR WITH THIS MEDICAL DEVICE? YES. WAS THIS HIS 1ST USE? BETWEEN 2 AND 10 POSES? OR MORE THAN 10 POSES? 2 POSES. DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? NO. REQUEST TO RECOVER THE SCREW FOR EXPERTISE IF AVAILABLE. JULY 09, 2025 RESULT OF THE EXPERTISE. BATCH 230593 COMPLIES WITH PRODUCTION SPECIFICATIONS. THE SCREW HAS A FRACTURED TIP AND DAMAGED THREADS AT THE ENTRY CONE. THE LATTER LIE BOTH FORWARD AND BACKWARD. THE INITIAL LENGTH OF THE SCREW WAS 30,2MM, HERE IT MEASURES 27,8MM => THE FIRST THREE MILLIMETERS OF THE SCREW WERE CUT DURING THE SCREWING ATTEMPT. THE SCREW WAS DAMAGED ON 12,7MM. SCREW DIAMETER: 10,1MM - THE MAXIMUM DIAMETER OF THE DAMAGED AREA IS 8,5MM. THICKNESS OF THE SCREW TIP MEASURED ON A SAMPLE TAKEN DURING MANUFACTURING: 2,9MM => COMPLIANT. THE RECESS BEGINS 0,2MM BELOW THE HEAD : CONTROL OF THE GUIDE LENGTH OF THE PIN ON SCREWS REJECTED AT THE START OF MANUFACTURING: 3MM. THE POSITIONING OF THE PIN DURING PREPARATION OF THE INJECTION MOLD COMPLIES WITH THE OPERATING MODE SBM MOP-MT-033. CHECKING THE RECESS WITH A Ø9/10/11 SCREWDRIVER (LOT 203204): ALL CLEAR, THE SCREWDRIVER EASILY ENTERS THE SCREW RECESS. GOOD VISIBILITY OF TCP GRANULES. OBSERVATION OF THE SCREW REVEALS A FRACTURE OF THE SCREW AT THE TIP (RECESS JUNCTION / GUIDE PIN PASSAGE HOLE) TO WHICH IS ADDED DAMAGE TO THE THREADS PRESENT ON THE ENTRY CONE. THEY LIE FORWARD AND BACKWARD. BREAKAGE OF THE TIP IS THE RESULT OF COMBINED SCREWING AND COMPRESSION FORCES EXERTED ON THE TIP OF THE SCREW DUE TO DIFFICULTIES ENCOUNTERED BY THE SURGEON IN INTRODUCING THE SCREW INTO THE TUNNEL. THE HYPOTHESES THAT COULD EXPLAIN THIS BREAKAGE IS AS FOLLOWS: 1. 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. FAILURE TO PRE-TAP THE TUNNEL USING THE APPROPRIATELY SIZED TAP INCREASES THE RISK OF THE SCREW BREAKING WHEN INSERTING IT INTO THE TUNNEL. 2. A TUNNEL DIAMETER SMALLER THAN THE SCREW DIAMETER GENERATED HIGH FRICTION FORCES OVER THE ENTIRE SURFACE OF THE SCREW WHEN PASSING THE CORTICAL WALL. ALL OF THESE CONSTRAINTS CAUSED A DEFORMATION OF THE SCREWDRIVER CAVITY: THE DEFORMATION BEING ALMOST ZERO AT THE END OF THE SCREWDRIVER CAVITY 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. HERE, THE TUNNEL HAS A DIAMETER OF 9 MM FOR A 10 MM DIAMETER SCREW, AND THE ENTRANCE HAS NOT BEEN TAPPED: NON-COMPLIANCE WITH SURGICAL TECHNIQUE. THE RESULT OF THE APPRAISAL IS FORWARDED TO OUR DISTRIBUTOR. NO ACTION IMPLEMENTED. THIS FILE IS CLOSED.
(B)(4) INCIDENT OCCURED IN INDIA. COMPLAINT DESCRIPTION: "SURGEON WAS DOING ACL SURGERY AND DURING THE INSERTION OF ACL SCREW. IT HAS BEEN BREAK AND THEN USED ANOTHER SCREW".
FNCONF-25-0050. INCIDENT OCCURED IN INDIA. COMPLAINT DESCRIPTION: "SURGEON WAS DOING ACL SURGERY AND DURING THE INSERTION OF ACL SCREW. IT HAS BEEN BREAK AND THEN USED ANOTHER SCREW".
FNCONF-25-0050. INCIDENT OCCURED IN INDIA. COMPLAINT DESCRIPTION: "SURGEON WAS DOING ACL SURGERY AND DURING THE INSERTION OF ACL SCREW. IT HAS BEEN BREAK AND THEN USED ANOTHER SCREW".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655221 | RESORBABLE INTERFERENCE SCREW | COMPOSITCP60 RESORBABLE INTERFERENCE SCREW - FLAT HEAD Ø10MM L30MM | MAI | S.B.M. SAS | 230593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Male | Other |