UNKNOWN PROFYLE 1.7MM SCREW
Report
- Report Number
- 0008031020-2022-00467
- Event Type
- Injury
- Date Received
- September 23, 2022
- Date of Event
- March 16, 2021
- Report Date
- November 16, 2022
- Manufacturer
- STRYKER GMBH
- Product Code
- LXH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHINA MEDICAL UNIVERSITY HOSPITAL, TAIWAN¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-021-04163-2. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
CORRECTION: H6 RESULTS CODE, CONCLUSION CODE THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF IMPLANT LOOSENING WAS OBSERVED IN ONE PATIENT. RADIOGRAPHS AT THE 2-MONTH FOLLOW-UP VISIT SHOWED LOSS OF REDUCTION AND SCREW LOOSENING . THE IMPLANT WAS REMOVED AFTER BONE UNION WAS OBSERVED ; HOWEVER, AN EXTENSION LAG OF 30°PERSISTED COULD BE CONFIRMED, FROM THE AVAILABLE RADIOGRAPHS IN THE LITERATURE. BASED ON THE AVAILABLE X-RAY A FORMAL MEDICAL OPINION WAS SOUGHT THAT STATED; "LOSS OF REDUCTION WAS FOUND IN ONE CASE OF BONY MALLET FRACTURE WITH DIP JOINT SUBLUXATION AND MORE THAN 60% JOINT SURFACE INVOLVEMENT. THE IMMEDIATE POSTOPERATIVE RADIOGRAPH SHOWED A SUBOPTIMAL POSITION OF THE PLATE, AND THE SCREW WAS INSERTED THROUGH THE FRACTURE SITE AND FAILED TO PURCHASE THE FAR CORTEX. THE RADIOGRAPH AT THE 2-MONTH FOLLOW-UP VISIT SHOWED SCREW LOOSENING AND LOSS OF REDUCTION. THERE SEEMS TO BE INSTANCES OF DEVICE THAT LED TO ALLEGED EVENT." FROM THE MEDICAL OPINION THE PRIMARY ROOT CAUSE CAN BE ATTRIBUTED TO AS USER RELATED FACTOR. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHINA MEDICAL UNIVERSITY HOSPITAL, TAIWAN¿. THE TITLE OF THIS REPORT IS ¿FUNCTIONAL OUTCOMES AND COMPLICATIONS OF HOOK PLATE FOR BONY MALLET FINGER: A RETROSPECTIVE CASE SERIES STUDY¿, PUBLISHED ON MARCH 16, 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-021-04163-2. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿PROFYLE HAND SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 16 PATIENTS. THE CASES IN THIS STUDY RANGE FROM JANUARY 2015 TO JULY 2020. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED IMPLANT LOOSENING, LOSS OF REDUCTION AND SCREW LOOSENING, WHICH REQUIRED IMPLANT REMOVAL. THE REPORT STATES, ¿IMPLANT LOOSENING WAS OBSERVED IN ONE PATIENT. RADIOGRAPHS AT THE 2-MONTH FOLLOW-UP VISIT SHOWED LOSS OF REDUCTION AND SCREW LOOSENING. THE IMPLANT WAS REMOVED AFTER BONE UNION WAS OBSERVED; HOWEVER, AN EXTENSION LAG OF 30°PERSISTED¿. THE REPORT ALSO STATES¿ LOSS OF REDUCTION WAS FOUND IN ONE CASE (CASE 9) OF BONY MALLET FRACTURE WITH DIP JOINT SUBLUXATION AND MORE THAN 60% JOINT SURFACE INVOLVEMENT. THE IMMEDIATE POSTOPERATIVE RADIOGRAPH SHOWED A SUBOPTIMAL POSITION OF THE PLATE, AND THE SCREW WAS INSERTED THROUGH THE FRACTURE SITE AND FAILED TO PURCHASE THE FAR CORTEX. THE RADIOGRAPH AT THE 2-MONTH FOLLOW-UP VISIT SHOWED SCREW LOOSENING AND LOSS OF REDUCTION.¿
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHINA MEDICAL UNIVERSITY HOSPITAL, TAIWAN¿. THE TITLE OF THIS REPORT IS ¿FUNCTIONAL OUTCOMES AND COMPLICATIONS OF HOOK PLATE FOR BONY MALLET FINGER: A RETROSPECTIVE CASE SERIES STUDY¿, PUBLISHED ON MARCH 16, 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-021-04163-2. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿PROFYLE HAND SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 16 PATIENTS. THE CASES IN THIS STUDY RANGE FROM JANUARY 2015 TO JULY 2020. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED IMPLANT LOOSENING, LOSS OF REDUCTION AND SCREW LOOSENING, WHICH REQUIRED IMPLANT REMOVAL. THE REPORT STATES, ¿IMPLANT LOOSENING WAS OBSERVED IN ONE PATIENT. RADIOGRAPHS AT THE 2-MONTH FOLLOW-UP VISIT SHOWED LOSS OF REDUCTION AND SCREW LOOSENING. THE IMPLANT WAS REMOVED AFTER BONE UNION WAS OBSERVED; HOWEVER, AN EXTENSION LAG OF 30°PERSISTED¿. THE REPORT ALSO STATES¿ LOSS OF REDUCTION WAS FOUND IN ONE CASE (CASE 9) OF BONY MALLET FRACTURE WITH DIP JOINT SUBLUXATION AND MORE THAN 60% JOINT SURFACE INVOLVEMENT. THE IMMEDIATE POSTOPERATIVE RADIOGRAPH SHOWED A SUBOPTIMAL POSITION OF THE PLATE, AND THE SCREW WAS INSERTED THROUGH THE FRACTURE SITE AND FAILED TO PURCHASE THE FAR CORTEX. THE RADIOGRAPH AT THE 2-MONTH FOLLOW-UP VISIT SHOWED SCREW LOOSENING AND LOSS OF REDUCTION.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553528 | UNKNOWN PROFYLE 1.7MM SCREW | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |