7.3MM CANNULATED LOCKING SCREW 85MM
Report
- Report Number
- 2939274-2021-07300
- Event Type
- Injury
- Date Received
- December 30, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWC
- UDI-DI
- 10886982051868
- PMA / PMN Number
- K000066
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HTY JDW 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HTY JDW 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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) 2021, THE 4.5MM LCP PROXIMAL FEMUR PLATE WITH BROKEN 7.3MM CANNULATED LOCKING SCREWS LOSS OF REDUCTION. THE DATE AND LOCATION OF THE ORIGINAL FIXATION ARE UNKNOWN. HARDWARE WAS REMOVED BY THE SURGEON ON THURSDAY, (B)(6) 2021. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED LOCKING SCREW 85MM. THIS REPORT IS 2 OF 2 FOR (B)(4).
IT WAS REPORTED THAT ON (B)(6) 2021, THE 4.5MM LCP PROXIMAL FEMUR PLATE WITH BROKEN 7.3MM CANNULATED LOCKING SCREWS LOSS OF REDUCTION. THE DATE AND LOCATION OF THE ORIGINAL FIXATION ARE UNKNOWN. HARDWARE WAS REMOVED BY THE SURGEON ON THURSDAY, (B)(6) 2021. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED LOCKING SCREW 85MM. THIS REPORT IS 2 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2021072 | 7.3MM CANNULATED LOCKING SCREW 85MM | SCREW,FIXATION,BONE | HWC | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 02.207.085 | 10886982051868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | 4.5 LCP PROXIMAL FEMUR PL 14 H/355-LFT| UNK - SCREWS: LOCKING |