Arthrex® AR-8943BL-05Recalls & reported problems
Arthrex, Inc. · LOCK DISTAL FIBULA PLT,SS LFT,5H · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867052529), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanics Altered” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Mechanics Altered1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2018Mechanics Altered
IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0 MM DRILL. ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) REGIONAL HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. (B)(6). THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05, AR-8835-12 (QTY. 2), AR-8830-14 (QTY. 1), AR-8835-14 (QTY. 1), AR-8827L-14 (QTY. 3), AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2 MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731 // LOT: 10158067 // LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLATE. TH
Patient problems: No Code Available
MAUDE report 7625162 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page