UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW
Report
- Report Number
- 0008031020-2022-00137
- Event Type
- Injury
- Date Received
- April 4, 2022
- Date of Event
- January 31, 2017
- Report Date
- March 27, 2024
- Manufacturer
- STRYKER GMBH
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED COMPLEX REGIONAL PAIN SYNDROME 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 MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
CORRECTION: H1: THIS IS NOT A SUMMARY REPORT. THE NUMBER OF EVENTS SUMMARIZED FIELD IS BLANK AS THIS MDR SUBMISSION PERTAINS TO ONE PATIENT. LINK TO THE PUBLISHED ARTICLE: HTTPS://DOI.ORG/10.1186/S12891-017-1414-7.
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF TRAUMA AND ORTHOPEDIC SURGERY, SECTION FOR RECONSTRUCTIVE AND HAND SURGERY, FEDERAL ARMED FORCES HOSPITAL WESTERSTEDE, GERMANY. THE TITLE OF THIS REPORT IS ¿MODIFIED MINIMALLY INVASIVE EXTENSOR CARPI RADIALIS LONGUS TENODESIS FOR SCAPHOLUNATE DISSOCIATION: A PROSPECTIVE OBSERVATIONAL STUDY¿ PUBLISHED ON JANUARY 31, 2017, WHICH IS ASSOCIATED WITH THE STRYKER ¿ASNIS III CANNULATED SCREW¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-017-1414-7. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 54 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM SEPTEMBER 2008 TO JUNE 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME. THE REPORT STATES, ¿DEVELOPMENT OF A NEUROMA, SCREW FAILURE, AS WELL AS COMPLEX REGIONAL PAIN SYNDROME WAS REPORTED IN ONE PATIENT EACH (2.2%). NONE OF THE PATIENTS REPORTED A RECURRENCE OF SYMPTOMS.¿
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF TRAUMA AND ORTHOPEDIC SURGERY, SECTION FOR RECONSTRUCTIVE AND HAND SURGERY, FEDERAL ARMED FORCES HOSPITAL WESTERSTEDE, GERMANY. THE TITLE OF THIS REPORT IS ¿MODIFIED MINIMALLY INVASIVE EXTENSOR CARPI RADIALIS LONGUS TENODESIS FOR SCAPHOLUNATE DISSOCIATION: A PROSPECTIVE OBSERVATIONAL STUDY¿ PUBLISHED ON JANUARY 31, 2017, WHICH IS ASSOCIATED WITH THE STRYKER ¿ASNIS III CANNULATED SCREW¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-017-1414-7. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 54 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM SEPTEMBER 2008 TO JUNE 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME. THE REPORT STATES, ¿DEVELOPMENT OF A NEUROMA, SCREW FAILURE, AS WELL AS COMPLEX REGIONAL PAIN SYNDROME WAS REPORTED IN ONE PATIENT EACH (2.2%). NONE OF THE PATIENTS REPORTED A RECURRENCE OF SYMPTOMS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1166746 | UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW | SCREW, FIXATION, BONE | HWC | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |