TOWER WRIST JOINT
Received Feb 4, 2019 · Event occurred Jan 10, 2019
Report 3025141-2019-00099 · MDR key 8301468
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Acumed LlcModel number
10100014Catalog number
10100014
Lot number
364026
Product problems
- Peeled/Delaminated
Patient
51 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
RETURNED PRODUCT EXAMINED VISUALLY UNDER MAGNIFICATION. ALL THREADED FEATURES WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. WELDS CONNECTING THE ARM SLEEVES TO THE LOCKING JOINT HAVE CRACKED. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2019-00097: ROSETTE KNOB 1, 3025141-2019-00098: ROSETTE KNOB 2, 3025141-2019-00100: TOWER UPPER ARC.
Description of Event or Problem
DURING SURGERY ON THE PATIENT'S ARM, IT WAS SUPPORTED BY THE ARC WRIST TOWER. DURING THE SURGERY, THE SURGEON FOUND TINY METAL FLAKES IN THE WOUND. THE FLAKES WERE COMING FROM THE ARC WRIST TOWER. ALL OF THE METAL FLAKES WERE NOT SUCCESSFULLY REMOVED FROM THE WOUND, AS SOME WERE STICKING TO THE SYNOVIUM EVEN WHEN WASHED THOROUGHLY. THERE WAS A DELAY IN SURGERY AS A RESULT OF THIS SITUATION.