DISTAL CLAVICLE PLATE, 10 HOLE, RIGHT
Report
- Report Number
- 1220246-2024-00862
- Event Type
- Injury
- Date Received
- February 8, 2024
- Date of Event
- June 30, 2023
- Report Date
- April 15, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRS
- PMA / PMN Number
- K123241
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFO: B5 EVENT UPDATED. G3 FOLLOW-UP INFORMATION RECEIVED.
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.
ADDITIONAL INFORMATION RECEIVED ON 1/23/2024: DURING THE ORIGINAL PROCEDURE ON 4/28/2023, AN AR-2685DR-10 DISTAL CLAVICLE PLATE, AN AR-8827L-20 LOW PROFILE LOCKING SCREW, (4) AR-8827L-18 LOW PROFILE LOCKING SCREW, (2) AR-8835-16 LOW PROFILE SCREW, AN AR-8835-18 LOW PROFILE SCREW, (2) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW WERE IMPLANTED. DURING THE REVISION SURGERY ON (B)(6) 2023, ALL THE IMPLANTS WERE SUCCESSFULLY REMOVED. THE REVISION SURGERY WAS COMPLETED USING AN AR-2653CR CLAVICLE FRACTURE PLATE, (3) AR-8835-18 LOW PROFILE SCREW, (3) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW. BOTH PROCEDURES WERE COMPLETED AT THE SAME FACILITY AND BY THE SAME SURGEON.
ON 1/18/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2685DR-10 DISTAL CLAVICLE PLATE BROKE EIGHT WEEKS POST-OPERATIVE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT COMMINUTED MID-SHIFT CLAVICLE FRACTURE. EIGHT WEEKS LATER, THE PATIENT RETURNED TO THE CLINIC, EXPERIENCING PAINFUL POPS IN THE SHOULDER. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE AR-2685DR-10 DISTAL CLAVICLE PLATE. THE REVISION SURGERY WAS A REVISION OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT CLAVICLE FRACTURE WITH ILIAC BONE GRAFT AND RIGHT CLAVICLE HARDWARE REMOVAL. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1874397 | DISTAL CLAVICLE PLATE, 10 HOLE, RIGHT | BONE FIXATION PLATE | HRS | ARTHREX, INC. | DISTAL CLAVICLE PLATE, 10 HOLE, RIGHT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |