3.5MM CORTEX SCREW SELF-TAPPING 12MM
Report
- Report Number
- 2939274-2022-00646
- Event Type
- Injury
- Date Received
- February 24, 2022
- Date of Event
- January 1, 2022
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWC
- UDI-DI
- 10886982146243
- PMA / PMN Number
- K131186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL NARRATIVE: ONLY EVENT YEAR IS KNOWN. ADDITIONAL DEVICE PRODUCT CODES: JDS AND HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
ADDITIONAL NARRATIVE: ONLY EVENT YEAR IS KNOWN. ADDITIONAL DEVICE PRODUCT CODES: JDS AND HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 11 OF 14 FOR (B)(4).
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 11 OF 14 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1456272 | 3.5MM CORTEX SCREW SELF-TAPPING 12MM | SCREW, FIXATION, BONE | HWC | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 204.812 | 10886982146243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 3.5MM CORTEX SCREW SELF-TAPPING 12MM| 3.5MM CORTEX SCREW SELF-TAPPING 12MM| 3.5MM CORTEX SCREW SELF-TAPPING 12MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| 3.5MM CORTEX SCREW SELF-TAPPING 14MM| LCP 3.5 6HO L85 SST| LCP 3.5 6HO L85 SST |