3.5MM CORTEX SCREW SELF-TAPPING 55MM
Report
- Report Number
- 1818910-2017-11465
- Event Type
- Injury
- Date Received
- January 26, 2017
- Date of Event
- June 10, 2016
- Report Date
- January 11, 2017
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K131186
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: JDS. THE FOLLOWING PARTS WERE REPORTED. IT IS UNKNOWN WHICH AND WHAT AMOUNTS OF THESE SCREWS ARE BROKEN. (PART # 204.814) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. (PART # 204.816) 3.5MM CORTEX SCREW SELF-TAPPING 16MM. (PART # 204.860) 3.5MM CORTEX SCREW SELF-TAPPING 60MM. (PART # 204.855) 3.5MM CORTEX SCREW SELF-TAPPING 55MM. (PART # 204.818) 3.5MM CORTEX SCREW SELF-TAPPING 18MM. (B)(4). 510K #'S: (PART # 204.814) # K131186. (PART # 204.816) # K131186. (PART # 204.860) # K112583. (PART # 204.855) # K131186. (PART # 204.818) # K131186. CORRECTED DATA: UPON RECEIPT OF THE ADDITIONAL INFORMATION IT WAS DETERMINED THAT THE REPORT SHOULD BE SERIOUS INJURY WITH REPORTED PRODUCT PROBLEM/ MALFUNCTION. 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.
THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS 170 CENTIMETERS. ADDITIONAL DEVICE PRODUCT CODE: HWC. (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE PERFORMED ON PART # 204.855 AND LOT # 0225201651, AS THE PROVIDED LOT NUMBER IS THE INVALID LOT NUMBER. 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.
THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INITIALLY IT WAS BELIEVED THE INVOLVED PARTS WERE DEPUY PARTS. AFTER ADDITIONAL INFORMATION WAS RECEIVED, IT WAS DETERMINED THEY WERE SYNTHES PARTS. REPORT SHOULD SERIOUS INJURY/ADVERSE EVENT ONLY; THERE WAS NO REPORTED PRODUCT PROBLEM/MALFUNCTION. 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.
THE FOLLOWING PARTS WERE REPORTED; 3.5MM CORTEX SCREW SELF-TAPPING 14MM, 3.5MM CORTEX SCREW SELF-TAPPING 16MM, 3.5MM CORTEX SCREW SELF-TAPPING 60MM, 3.5MM CORTEX SCREW SELF-TAPPING 55MM, 3.5MM CORTEX SCREW SELF-TAPPING 18MM. IT IS UNKNOWN WHICH AND WHAT AMOUNTS OF THESE SCREWS ARE BROKEN.
CLAIM LETTER RECEIVED STATING PATIENT IS SEEKING COMPENSATION. THE PRODUCT AT ISSUE IS BROKEN CORTICAL SCREWS THAT WERE IMPLANTED INTO THE PATIENT'S ANKLE.
IT WAS REPORTED THAT INITIALLY, THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN (B)(6) 2016 AND SUFFERED A FRACTURED RIGHT ANKLE FRACTURE WITH SYNDESMOTIC DISRUPTION AND CONCUSSION WITH LOSS OF CONSCIOUSNESS. PATIENT WAS FOUND TO HAVE A SEVERELY SHORTENED AND DISPLACED WEBER C FIBULAR FRACTURE. ON (B)(6) 2016, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF). THE FRACTURE WAS REDUCED WITH AN UNKNOWN SYNTHES LOCKING COMPRESSION/DYNAMIC COMPRESSION (LCDC) PLATE AND AN UNKNOWN AMOUNT OF BICORTICAL SCREWS PROXIMAL AND DISTALLY. TWO (2) 3.5MM SYNDESMOTIC SCREWS WERE IMPLANTED. MULTIPLANAR FLUOROSCOPY IMAGING WAS PERFORMED WHICH SHOWED SATISFACTORY FRACTURE REDUCTION AND HARDWARE PLACEMENT. PATIENT WAS IN GOOD CONDITION IN POSTOPERATIVE RECOVERY. THE FRACTURE HAD HEALED. ON (B)(6) 2016, DUE TO PAINFUL HARDWARE, TWO (2) SYNDESMOTIC/CORTICAL SCREWS (ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 55MM AND (1) 3.5MM CORTEX SCREW SELF-TAPPING 18MM) OF THE RIGHT ANKLE WERE NOTED TO BE BENT AND BROKEN. THE REMAINING PORTIONS OF THE SCREW REMAINED IN THE METAPHYSIS OF THE DISTAL TIBIA. THE PROCEDURE WENT WELL AND THE PATIENT WAS IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION/DYNAMIC COMPRESSION (LCDC) PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART # 204.814, LOT # UNKNOWN, QUANTITY # UNKNOWN), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART # 204.816, LOT # UNKNOWN, QUANTITY # UNKNOWN), 3.5MM CORTEX SCREW SELF-TAPPING 60MM (PART # 204.860, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
IT WAS REPORTED THE PATIENT HAD A SCREW REMOVED ON (B)(6) 2016. IT IS UNKNOWN IF THE SCREW WAS BROKEN OR IF IT HAD TO BE REMOVED FOR ANOTHER REASON. IT IS UNKNOWN IF ANY ADDITIONAL HARDWARE WAS REMOVED OR IF THE PATIENT WAS REVISED WITH OTHER HARDWARE. NO REPORTED SURGICAL DELAY OR PATIENT HARM DURING REMOVAL PROCEDURE. INITIALLY, THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN (B)(6) 2016 AND SUFFERED A FRACTURED DISTAL FIBULA. A SURGERY WAS PERFORMED ON (B)(6) 2016 AND THE PATIENT WAS IMPLANTED WITH SYNDESMOTIC SCREWS. THE PATIENT WAS EXPERIENCING PAIN AND WENT BACK FOR A CONSULTATION. IT WAS DETERMINED THAT A SCREW NEEDED TO BE REMOVED. NO REPORT OF SURGICAL DELAY OR PATIENT HARM DURING THE INITIAL PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE UNKNOWN CORTEX SCREW (SYNDESMOTIC PLACEMENT) FOR THE DISTAL FIBULA. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61791 | 3.5MM CORTEX SCREW SELF-TAPPING 55MM | PLATE, FIXATION, BONE | HWC | SYNTHES MONUMENT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |