ALPHA PLATE, LEFT, 11 HOLE
Report
- Report Number
- 1220246-2025-09465
- Event Type
- Injury
- Date Received
- January 15, 2025
- Date of Event
- December 19, 2024
- Report Date
- July 16, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: B1, B2, B5, D1, D4, D6A, D6B, G3, G4, H1, H6.
CORRECTION: B5.
THE COMPLAINT ALLEGATION THAT AN ALPHA PLATE BROKE POSTOPERATIVELY IS CONFIRMED. ONE UNPACKAGED 3024-011, ALPHA PLATE, LEFT, 11 HOLE, BATCH NUMBER 220705, WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION NOTED THAT THE PLATE BROKE AT THE OBLONG HOLE IN THE ANTERIOR BEND. ADDITIONALLY, THE THREADS INSIDE THE HOLES ALONG THE PLATE HAD DAMAGE, LIKELY DUE TO THE IMPLANTATION AND EXPLANATION PROCESS. THE DEVICE ALSO EXHIBITED DISCOLORATION, CHIPPING, AND SURFACE WEAR. FUNCTIONAL TESTING NOTED THAT THE THREADS OF THE PLATE WERE DAMAGED, AND THE SCREWS WERE MET WITH RESISTANCE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.
ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ALPHA PLATE BROKE POSTOPERATIVELY. THE PATIENT WAS PICKING UP THE CAT AND FELT A BREAK. X-RAYS CONFIRM THE PLATE BROKE THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
ADDITIONAL INFORMATION RECEIVED ON 2/6/2025: ON (B)(6) 2023, THE PATIENT UNDERWENT A PROXIMAL HUMERUS FRACTURE PROCEDURE. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW WERE IMPLANTED. DUE TO NONUNION, THE PATIENT UNDERWENT A SECOND SURGERY ON 10/29/2024 TO HAVE AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE IMPLANTED. ALL THE PREVIOUSLY IMPLANTED PRODUCTS DURING THE INITIAL SURGERY ON 12/21/2023 REMAINED IN THE PATIENT. A COUPLE OF MONTHS LATER, THE 3024-011 LEFT ALPHA PLATE BROKE. THE PATIENT UNDERWENT REVISION SURGERY ON 12/24/2024 TO HAVE BOTH PLATES AND ALL THE SCREWS REMOVED. DURING THE REMOVAL OF THE SCREWS, TWO BROKE OFF. AT THIS TIME, IT IS UNKNOWN WHAT WERE THE PART NUMBERS OF THE BROKEN SCREWS AND IF THEY WERE FULLY REMOVED FROM THE PATIENT. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.
ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ALPHA PLATE BROKE POSTOPERATIVELY. THE PATIENT WAS PICKING UP THE CAT AND FELT A BREAK. X-RAYS CONFIRM THE PLATE BROKE THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 02/06/2025: ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT ALPHA PLATE BREAKING AND CAUSING THE REINFORCED STRAIGHT PLATE TO DISLODGE. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW, AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE WERE EXPLANTED DURING THE REVISION SURGERY. DURING THE REMOVAL OF THE SCREWS, TWO BROKE OFF. AT THIS TIME, IT IS UNKNOWN WHAT WERE THE PART NUMBERS OF THE BROKEN SCREWS AND IF THEY WERE FULLY REMOVED FROM THE PATIENT. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 931822 | ALPHA PLATE, LEFT, 11 HOLE | BONE FIXATION PLATE | HRS | ARTHREX, INC. | ALPHA PLATE, LEFT, 11 HOLE | 220705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |