INTERFERENCE SCREW
Report
- Report Number
- 3004549189-2020-00009
- Event Type
- Injury
- Date Received
- May 7, 2020
- Date of Event
- February 23, 2017
- Report Date
- August 18, 2020
- Manufacturer
- S.B.M. SAS
- Product Code
- MAI
- PMA / PMN Number
- K122228
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
REQUEST FOR FURTHER INFORMATION: EMAIL TRANSMITTED TO OUR DISTRIBUTOR ON 23 APRIL 2020. "YOUR COMPLAINT WAS REGISTERED. PLEASE FIND ATTACHED THE ACKNOWLEDGMENT OF RECEIPT CONCERNING THIS FILE. WE NOTE THE NEED OF NEW SURGICAL INTERVENTIONS ON 2017 IMPLIES AN INCIDENT REPORT. TO COMPLETE OUR INVESTIGATION, WE NEED ADDITIONAL INFORMATION: COULD YOU PLEASE TRANSMIT US INFORMATION CONCERNING THE MEDICAL DEVICE (BATCH NUMBER OR PRODUCT NAME OR REFERENCE OR PHOTO OF THE BOX / LABELS [?]): YOUR MESSAGE INDICATES "PART#: SPM-UNKNOWN-LACTOSORB, LOT#: UNKNOWN" AND WE NEED TO IDENTIFY IF THE PRODUCT IS REALLY MANUFACTURED BY US. "SPM" COULD BE PORTUGUESE SOCIETY OF MATERIALS AND NOT "SBM" SCIENCE & BIO MATERIALS. COULD YOU PLEASE CONFIRM YOUR COMPLAINT ABOUT THIS PRODUCT? OTHER QUESTIONS IF SBM PRODUCT IS CONFIRMED: WHAT IS THE PATIENT'S CONDITION TODAY? HEALTH FACILITY AND SURGEON INFORMATION OF INITIAL SURGERY? (EVENT DATE: ON (B)(6) 2016). HEALTH FACILITY INFORMATION OF RUPTURE REPAIR SURGERY? (RUPTURE REPAIR ON (B)(6) 2017, DOCTOR: DR. (B)(6). HEALTH FACILITY AND SURGEON INFORMATION OF SURGERY TO RESOLVE CYCLOPES SYNDROME ON (B)(6) 2017 WITH ARTHROLYSIS?" FOLLOW UP 1 / RESULT OF INVESTIGATION: PRODUCT ELEMENT OF THE COMPLAINT: MEDICAL DEVICE: PART#: SPM-UNKNOWN-LACTOSORB, LOT#: UNKNOWN. QTY- 2. THE MANUFACTURING OF THESE MEDICAL DEVICES BY SBM WAS NOT CONFIRMED. ADDITIONAL INFORMATION TRANSMITTED BY NELLY BRIQUET, CLINICAL PROJECT JR. LEAD - EMEA MDR SPORTS MEDICINE: THIS FILE CONCERNS PATIENT (B)(6). DATE OF THE INCIDENT IS IN FACT ON (B)(6) 2017. UPDATE FOR RUPTURE REPAIR SURGERY: ON (B)(6) 2017 - LEFT KNEE. UPDATE FOR SURGERY TO RESOLVE CYCLOPES SYNDROME: ON (B)(6) 2017 - RIGHT KNEE. REFERENCE NUMBERS SHE RECEIVED FROM THE SURGEON FOR THE IMPLANTS USED IN PATIENTS#: (B)(6): TIBIAL SCREW : COMPOSITCP : 170719 ; FEMORAL SCREW: GENTLETHREADS LACTOSORB : 292570. WE HAVE IDENTIFIED THAT THE PRODUCT "SPM-UNKNOWN-LACTOSORB" IS NOT MANUFACTURED BY SBM. FEMORAL SCREW GENTLETHREADS LACTOSORB : 292570 (THIS IS NOT A SBM REFERENCE NUMBER OR A LOT NUMBER). WE HAVE IDENTIFIED PART NUMBER AND LOT NUMBER OF SBM PRODUCT: TIBIAL SCREW PART NUMBER: 905216 - DESIGNATION: COMPOSITCP 30, 9X25MM INT. SCR. DRG#: 9052-16/18-00, LOT NUMBER: 170719 (IT IS A SBM LOT NUMBER ; NOT A PART NUMBER). MANUFACTURED DATE: 27 FEB 2017, USE BEFORE: 27 FEB 2020. SO, IT APPEARS THAT THERE WAS A RUPTURE REPAIR SURGERY ON (B)(6) 2017 FOR THE LEFT KNEE, AND A SECOND SURGERY TO RESOLVE CYCLOPES SYNDROME ON (B)(6) 2017 FOR THE RIGHT KNEE. FURTHERMORE, THE SECOND PROCEDURE IS NOT RELATED TO THE FIRST (IT IS NOT THE SAME KNEE). ACCORDING TO THE INFORMATION PROVIDED IN THE DATABASE BY THE SURGEON, THERE IS NO CONNECTION BETWEEN EVENT AND THE MEDICAL DEVICE. FINALLY, THE MEDICAL DEVICE OF THIS COMPLAINT CORRESPONDS TO "FEMORAL SCREW GENTLETHREADS LACTOSORB". THIS IS NOT A SBM PRODUCT. NO CORRECTIVE ACTION IMPLEMENTED BY SBM. THIS FILE IS CLOSED.
FNC 2004/02032. COMPLAINT TRANSMITTED BY OUR DISTRIBUTOR ON 22 APRIL 2020: "WE RECEIVED A NEW COMPLAINT ON APR 08, 2020 FROM SWITZERLAND THROUGH CLINICAL STUDY REGARDING THE BELOW MENTIONED COMPLAINT EVENT: IT WAS REPORTED THE PATIENT UNDERWENT AN ACL RUPTURE REPAIR ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT IS UNABLE TO PERFORM RANGE OF MOTION AS EXPECTED. THE PATIENT WAS NOTED TO HAVE CYCLOPES SYNDROME WITH FIXED FLEXION CONTRACTURE THAT WAS NOTED TO BE RESOLVED ON (B)(6) 2017 WITH ARTHROLYSIS. EVENT DATE: ON (B)(6) 2016, PART#: SPM-UNKNOWN-LACTOSORB. LOT#: UNKNOWN, QTY- 2. IMPLANT DATE: ON (B)(6) 2017, DOCTOR: DR. (B)(6).
REQUEST FOR FURTHER INFORMATION: EMAIL TRANSMITTED TO OUR DISTRIBUTOR ON 23 APRIL 2020. "YOUR COMPLAINT WAS REGISTERED. PLEASE FIND ATTACHED THE ACKNOWLEDGMENT OF RECEIPT CONCERNING THIS FILE. WE NOTE THE NEED OF NEW SURGICAL INTERVENTIONS ON 2017 IMPLIES AN INCIDENT REPORT. TO COMPLETE OUR INVESTIGATION, WE NEED ADDITIONAL INFORMATION: - COULD YOU PLEASE TRANSMIT US INFORMATION CONCERNING THE MEDICAL DEVICE (BATCH NUMBER OR PRODUCT NAME OR REFERENCE OR PHOTO OF THE BOX / LABELS [?]): YOUR MESSAGE INDICATES "PART# SPM-UNKNOWN-LACTOSORB - LOT# UNKNOWN" AND WE NEED TO IDENTIFY IF THE PRODUCT IS REALLY MANUFACTURED BY US. "SPM" COULD BE (B)(4) SOCIETY OF MATERIALS AND NOT "SBM" SCIENCE & BIO MATERIALS. COULD YOU PLEASE CONFIRM YOUR COMPLAINT ABOUT THIS PRODUCT? OTHER QUESTIONS IF SBM PRODUCT IS CONFIRMED: - WHAT IS THE PATIENT'S CONDITION TODAY? - HEALTH FACILITY AND SURGEON INFORMATION OF INITIAL SURGERY? (EVENT DATE: (B)(6) 2016. - HEALTH FACILITY INFORMATION OF RUPTURE REPAIR SURGERY? (RUPTURE REPAIR ON (B)(6) 2017 - DOCTOR: DR. (B)(6)). - HEALTH FACILITY AND SURGEON INFORMATION OF SURGERY TO RESOLVE CYCLOPES SYNDROME ON (B)(6) 2017 WITH ARTHROLYSIS?". ____________________________________________________________________________________________________
(B)(4). COMPLAINT TRANSMITTED BY OUR DISTRIBUTOR ON 22 APRIL 2020: "WE RECEIVED A NEW COMPLAINT ON APR 08, 2020 FROM (B)(4) THROUGH CLINICAL STUDY REGARDING THE BELOW MENTIONED COMPLAINT EVENT: IT WAS REPORTED THE PATIENT UNDERWENT AN ACL RUPTURE REPAIR ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT IS UNABLE TO PERFORM RANGE OF MOTION AS EXPECTED. THE PATIENT WAS NOTED TO HAVE CYCLOPES SYNDROME WITH FIXED FLEXION CONTRACTURE THAT WAS NOTED TO BE RESOLVED ON (B)(6) 2017 WITH ARTHROLYSIS. EVENT DATE: (B)(6) 2016. PART# SPM-UNKNOWN-LACTOSORB. LOT# UNKNOWN. QTY- 2. IMPLANT DATE: (B)(6) 2017 DOCTOR: DR. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497395 | INTERFERENCE SCREW | INTERFERENCE SCREW | MAI | S.B.M. SAS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |