ALPHA PLATE, LEFT, 11 HOLE
Report
- Report Number
- 1220246-2024-08573
- Event Type
- Injury
- Date Received
- November 20, 2024
- Date of Event
- October 29, 2024
- Report Date
- February 27, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- KTW
- UDI-DI
- 00848665027815
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFORMATION.
THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 3024-011 ALPHA PLATE, LEFT, 11-HOLE, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS CONDUCTED BY SCREWING SOME OF THE RETURNED SCREWS INTO THE RETURNED 3024-011 ALPHA PLATE, LEFT, 11-HOLE, SERIAL/BATCH NUMBER (B)(6). IT WAS NOTED THAT THE BLUE SCREWS ATTACHED FLUSH AND FULLY TO THE HEAD HOLES WITHOUT ISSUES. THE GREEN SCREWS SAT FLUSH ONTO THE PLATE¿S HOLES, AND THE NON-LOCKING SCREWS DID NOT ATTACH TO THE PLATE BY THEMSELVES; HOWEVER, THIS IS EXPECTED AS THESE SCREWS ARE SCREWED DIRECTLY INTO THE BONE TO HOLD THE PLATE IN PLACE. NO ISSUES WERE IDENTIFIED WITH THE SCREW ATTACHMENTS DURING THE TEST. VISUAL INSPECTION REVEALED THAT THE PLATE BROKE AT THE OBLONG HOLE IN THE ANTERIOR BEND. SCRATCHES, DENTS, AND A LOSS OF THE DEVICE¿S MATERIAL COLOR WERE ALSO OBSERVED. THE DAMAGE IN THE THREADS OF THE HOLES IS MOST LIKELY ATTRIBUTED TO THE FACT THAT THEY WERE IMPLANTED AND REMOVED. A REVIEW OF THE PATIENT'S ATTACHED X-RAYS SHOWS THE FOLLOWING TIMELINE: ON (B)(6) 2024, THE PATIENT¿S X-RAY SHOWED A NON-ARTHREX PLATE IMPLANTED, WITH SOME SCREWS BROKEN AND DETACHED FROM THE PLATE. ON (B)(6) 2024, POST-OP X-RAYS SHOW THE POSITION OF THE ARTHREX PLATE. ALMOST TWO WEEKS LATER, ON (B)(6) 2024, X-RAYS SHOWED NO ISSUES WITH THE PLATE, AND THE FRACTURE WAS STILL PRESENT. ON (B)(6) 2024, SIX WEEKS LATER, X-RAYS SHOW THE BONE IS NOT HEALING. WHETHER THIS IS DUE TO A POOR REDUCTION BEFORE THE PLACEMENT OF THE PLATE, PATIENT BIOLOGY, OR OTHER FACTORS LEADING TO DELAYED HEALING (SMOKING, ALCOHOLISM, LACK OF ADHERENCE TO POST-OP PRECAUTIONS) IS UNCLEAR. HOWEVER, ANY PLATE WILL EVENTUALLY FAIL IF THE FRACTURE DOES NOT HEAL. ON (B)(6) 2024, SEVEN MONTHS AFTER THE SURGERY, THE PLATE BROKE AT THE OBLONG HOLE IN THE ANTERIOR BEND. BASED ON THE ATTACHED X-RAYS AND THE EVALUATION OF THE PLATE, THIS BREAKAGE EVENT WAS MOST LIKELY A PATIENT-SPECIFIC EVENT RELATED TO ONE OR A COMBINATION OF THE FOLLOWING FACTORS: 1. EXTREME STRESS OR STRAIN RESULTING FROM WORK, LIFESTYLE OR SPORT-RELATED ACTIVITY. 2. THE EXCESSIVE WEAKNESS OF THE BONE DUE TO THE FACT THAT THIS WAS THE PATIENT¿S SECOND PLATE IMPLANT. 3. POSTOPERATIVELY AND UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: DURING THE INITIAL SURGERY ON (B)(6) 2024, A 3024-011 11-HOLE LEFT ALPHA PLATE, TWO 8110-026 CORTICAL BONE SCREW, AN 8110-028 CORTICAL BONE SCREW, THREE 8110-030 CORTICAL BONE SCREWS, AN 8114-024 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-028 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-030 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-028 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, FULLY THREADED, AN 8124-038 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-050 FULLY THREADED CANCELLOUS LOCKING SCREW, AN AR-8935CL-18 KREULOCK COMPRESSION SCREW, AND AN ABS-2010-10 ALLOSYNC PURE WERE IMPLANT. AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT WAS ALSO USED DURING THE PROCEDURE. ON (B)(6) 2024, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. ALL THE HARDWARE FROM THE ORIGINAL SURGERY ON (B)(6) 2024 WAS REMOVED AND REPLACED WITH PRODUCTS FROM ANOTHER MANUFACTURER, A 10CC OF ARTHREX ALLOSYNC PURE DBM, 5CC OF ARTHREX ARTHROCELL PLUS, AND BONE MARROW ASPIRATE FROM THE ILIAC CREST.
ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-01 11-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND REVISION SURGERY IS STILL TO BE DETERMINED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2448656 | ALPHA PLATE, LEFT, 11 HOLE | BONE FIXATION PLATE | KTW | ARTHREX, INC. | ALPHA PLATE, LEFT, 11 HOLE | 220126A | 00848665027815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |