SCREW, FIXATION, BONE
Report
- Report Number
- 2520274-2015-15122
- Event Type
- Injury
- Date Received
- August 5, 2015
- Report Date
- July 15, 2015
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT WAS NOT PROVIDED BY REPORTER. IT IS UNCLEAR TO SYNTHES AT THIS TIME IF THESE DEVICES WERE THE SCREWS WHICH HAD LOOSENED AND/OR HAD BROKEN THEN LOOSENED POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT A RESPONSE HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. THIS REPORT IS FOR TWO UNKNOWN LOCKING SCREWS. PART AND LOT NUMBERS WERE NOT PROVIDED BY REPORTER. DATE OF IMPLANT WAS NOT PROVIDED BY REPORTER BUT WAS REPORTED AS APPROXIMATELY 3 MONTHS PRIOR TO (B)(6) 2015. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
TWO HEADS OF TWO (2) UNKNOWN LOCKING SCREWS WERE SENT BACK FOR EVALUATION, BASED ON THE SYSTEM IT CAN BE ASSUMED THAT THE SCREWS BELONG TO THE PART FAMILY 04.210.1XX AND ARE VA LOCKING SCREWS STARDRIVE®, SELF-TAPPING. HOWEVER THE COMPLETE SHAFT WAS NOT SENT BACK FOR EVALUATION, WHICH MAKES AN EXACT DETERMINATION OF THE PART NUMBER IMPOSSIBLE. ALSO THE LOT NUMBER WAS NOT PROVIDED, WHICH MAKES A REVIEW OF THE MANUFACTURING DOCUMENTS IMPOSSIBLE. THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE DUE TO THE KIND OF BREAKAGE, WHICH IS ON BOTH SCREWS AT A CROSSOVER, EITHER FROM THE SHAFT TO THE HEAD OR THE STARDRIVE TO THE HEAD. THE MICROSCOPIC VIEW HAS SHOWN THAT THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. FINALLY WE ARE BASED ON THE PROVIDED INFORMATION NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE AND IT IS LIKELY THAT COMPLICATION DURING THE HEALING PROCESS DID LEAD TO A FATIGUE FAILURE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO UNKNOWN LOCKING SCREWS BROKE AT THE HEAD OR LOOSENED FROM THE SHAFT APPROXIMATELY THREE (3) MONTHS POSTOPERATIVELY. THE DATE OF IMPLANT IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015, AND A 2.4MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) VOLAR DISTAL RADIUS PLATE, TWO 2.7MM CORTEX SCREWS, AND FOUR UNKNOWN SCREWS (INCLUDING TWO UNKNOWN LOCKING SCREWS WHICH REPORTEDLY BROKE OR LOOSENED AND TWO UNKNOWN CORTEX SCREWS) WERE EXPLANTED FROM THE PATIENT. THIS REPORT IS FOR TWO UNKNOWN LOCKING SCREWS. THIS REPORT IS 4 OF 4 FOR (B)(4).
ADDITIONAL INFORMATION: THE PROVIDED X-RAYS WERE REVIEWED BY A DEPUY SYNTHES MEDICAL DIRECTOR WHO CONFIRMED THE DEVICE LOOSENING. ADDITIONAL INFORMATION PROVIDED. EFFORTS ARE CURRENTLY BEING MADE REQUEST CLARIFICATION REGARDING HCP STATEMENT OF DEVICE LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513812 | SCREW, FIXATION, BONE | HWC | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |