LARGE COMBINATION CLAMP
Report
- Report Number
- 1220246-2026-02319
- Event Type
- Injury
- Date Received
- April 21, 2026
- Date of Event
- March 23, 2026
- Report Date
- April 21, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- MDM
- UDI-DI
- 00888867241251
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ON 01-APR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT SEVEN AR-8964-07 LARGE COMBINATION CLAMPS, FOUR AR-8964-27 STRAIGHT ATTACHMENT ARMS, TWO AR-8964-08 MULTI-PIN CLAMPS (LARGE), AND THREE AR-8964R-450 CARBON RODS (450 MM) WERE USED IN A KNEE-SPANNING EXTERNAL FIXATION CONSTRUCT WITH THE ARTHROFX EXTERNAL FIXATION SYSTEM DURING A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2026. THE CONSTRUCT INCLUDED TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE FEMUR AND TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE TIBIA TO ADDRESS A PROXIMAL TIBIAL FRACTURE. INTRAOPERATIVELY, THE SURGEON APPLIED DISTRACTION, BROUGHT THE FRACTURE TO LENGTH, TIGHTENED ALL COMBINATION CLAMPS, AND COMPLETED THE PROCEDURE WITHOUT ISSUE. WITHIN APPROXIMATELY 36¿48 HOURS POSTOPERATIVELY, FOLLOW-UP X-RAY IMAGING DEMONSTRATED LOSS OF FRACTURE REDUCTION, AND THE EXTERNAL FIXATOR WAS NOTED TO HAVE SLIPPED. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026. DURING THE REVISION, THE SURGEON INITIALLY ATTEMPTED TO REUSE THE EXISTING ARTHROFX 5 MM SCHANZ PINS; HOWEVER, WHEN DISTRACTION WAS APPLIED USING AN ALTERNATE MANUFACTURER¿S COMBINATION CLAMPS, INTRAOPERATIVE X-RAY IMAGING DEMONSTRATED BENDING OF THE ARTHROFX PINS. THE PINS WERE REMOVED, AND THE EXTERNAL FIXATOR WAS COMPLETED USING AN ALTERNATE MANUFACTURER¿S SYSTEM. NO PHYSICAL HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THE INSTRUMENTATION; HOWEVER, THE EXTERNAL FIXATOR FAILED TO MAINTAIN ITS INTENDED POSITION. ADDITIONAL INFORMATION WAS RECEIVED ON 08-APR-2026: BOTH THE INITIAL PROCEDURE AND THE REVISION SURGERY WERE PERFORMED AT THE SAME FACILITY, WITH DIFFERENT SURGEONS INVOLVED IN EACH PROCEDURE. ALL ARTHREX COMPONENTS IMPLANTED DURING THE INITIAL SURGERY WERE EXPLANTED DURING THE REVISION ON (B)(6) 2026, AND NO ARTHREX PRODUCTS REMAINED IMPLANTED FOLLOWING THE REVISION. ACCORDING TO THE PATIENT, THERE WERE NO REPORTED POSTOPERATIVE ISSUES PRIOR TO THE FOLLOW-UP X-RAY, WHICH DEMONSTRATED LOSS OF FRACTURE REDUCTION. IMAGING DEMONSTRATED MULTIPLE MILLIMETERS OF LOSS OF REDUCTION, WHICH REQUIRED REVISION WITHIN APPROXIMATELY 48 HOURS OF THE INITIAL IMPLANTATION. THE EXTERNAL FIXATOR WAS REPORTED TO HAVE SLIPPED AT THE CLAMP-TO-ROD INTERFACE. THE REVISING SURGEON ALSO NOTED THAT THE NUTS ON THE ARTHROFX COMBINATION CLAMPS APPEARED TO BE STRIPPED OR IN THE PROCESS OF STRIPPING. DURING THE REVISION ATTEMPT, FOUR ARTHROFX 5.0 MM SELF-DRILLING SCHANZ SCREWS THAT HAD BEEN IMPLANTED DURING THE INITIAL PROCEDURE WERE REUSED, INCLUDING TWO AR-8964-04 SCREWS PLACED IN THE FEMUR AND TWO AR-8964-03 SCREWS PLACED IN THE TIBIA. THESE PINS WERE RECLAMPED IN THE SAME POSITIONS USING NON-ARTHREX COMBINATION CLAMPS AND RODS. AFTER DISTRACTION WAS APPLIED AND FRACTURE ALIGNMENT WAS CONFIRMED VIA INTRAOPERATIVE IMAGING, SUBSEQUENT IMAGING DEMONSTRATED SIGNIFICANT BENDING OF THE TIBIAL PINS, WHILE THE FEMORAL PINS APPEARED UNAFFECTED. THE ARTHREX PINS WERE NOTED TO BE BENT SYMMETRICALLY. FOLLOWING THIS OBSERVATION, THE SURGEON SCRUBBED IN, REMOVED ALL REMAINING ARTHREX HARDWARE, AND COMPLETED THE REVISION SURGERY USING AN EXTERNAL FIXATION SYSTEM FROM AN ALTERNATE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1006761 | LARGE COMBINATION CLAMP | MANUAL INSTR, GENERAL SURGICAL | MDM | ARTHREX, INC. | LARGE COMBINATION CLAMP | 1592502 | 00888867241251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |